Trial Outcomes & Findings for Prospective Observational Study of the Power PICC Family of Devices and Accessories (NCT NCT04263649)

Last Updated: 2024-08-19

Results Overview

Incidence of symptomatic venous thrombosis defined as any new occurrence of symptomatic venous thrombosis defined by thrombus presence by ultrasonography or other imaging.

Recruitment status

COMPLETED

Target enrollment

450 participants

Primary outcome timeframe

from insertion though removal or 180 days, whichever comes first

Results posted on

2024-08-19

Participant Flow

The study was conducted at 14 centers in 9 European countries. The first participant was enrolled on June 18, 2020 and the last participant had the last study visit on January 05, 2022. The choice of the specific device type, size, number of lumens, and length required for an individual patient was left to the discretion of the clinician.

In this post market study, 450 patients, who were to receive a PICC from the PowerPICC family as per routine clinical practice, were observed for up to 180 days after device's insertion or until removal of the device because the therapy was completed, changed or cancelled. Patients, who died during the study and had the device in place at the time of death, were considered as having completed the therapy.

Participant milestones

Participant milestones
Measure	All Subjects Patients who received a device from the BD PowerPICC family according to the clinical practice.
Overall Study STARTED	450
Overall Study Receive Treatment Via the Study Device	447
Overall Study COMPLETED	335
Overall Study NOT COMPLETED	115

Reasons for withdrawal

Reasons for withdrawal
Measure	All Subjects Patients who received a device from the BD PowerPICC family according to the clinical practice.
Overall Study Adverse Event	53
Overall Study Lost to Follow-up	3
Overall Study Death	29
Overall Study Device deficiency	19
Overall Study other reasons	11

Baseline Characteristics

Prospective Observational Study of the Power PICC Family of Devices and Accessories

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=450 Participants Patients who received a device from the BD PowerPICC family according to the clinical practice.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) White	439 Participants n=99 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants
Age, Continuous	60 years STANDARD_DEVIATION 14.8 • n=99 Participants
Sex: Female, Male Female	226 Participants n=99 Participants
Sex: Female, Male Male	224 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	5 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=99 Participants
Region of Enrollment Netherlands	40 participants n=99 Participants
Region of Enrollment Austria	16 participants n=99 Participants
Region of Enrollment Belgium	10 participants n=99 Participants
Region of Enrollment Czechia	59 participants n=99 Participants
Region of Enrollment Denmark	59 participants n=99 Participants
Region of Enrollment Italy	212 participants n=99 Participants
Region of Enrollment Switzerland	27 participants n=99 Participants
Region of Enrollment Germany	21 participants n=99 Participants
Region of Enrollment Spain	6 participants n=99 Participants
Body Mass Index (BMI)	26.30 kg/m² STANDARD_DEVIATION 5.27 • n=99 Participants
Relevant medical history Implantable devices	11 Participants n=99 Participants
Relevant medical history Past and/or current anatomical abnormalities of the central venous system	6 Participants n=99 Participants
Relevant medical history Past and/or current atrial fibrillation or other atrial arrhythmias that affects the p-wave	36 Participants n=99 Participants
Relevant medical history Known absence of a p-wave	6 Participants n=99 Participants
Relevant medical history Abnormalities of the arms	7 Participants n=99 Participants
Relevant medical history Abnormalities of the chest wall	5 Participants n=99 Participants
Relevant medical history History of coagulopathy	9 Participants n=99 Participants
Relevant medical history History of hypercoagulopathy	2 Participants n=99 Participants
Relevant medical history Current treatment with anticoagulants	27 Participants n=99 Participants
Relevant medical history Central venous access devices	93 Participants n=99 Participants
Relevant medical history History of LN dissection/ lymphedema	49 Participants n=99 Participants
Relevant medical history Renal impairment	4 Participants n=99 Participants
Relevant medical history History of phlebitis	7 Participants n=99 Participants
Relevant medical history History of venous thrombosis	13 Participants n=99 Participants
Relevant medical history History of deep vein thrombosis	10 Participants n=99 Participants
Relevant medical history History of catheter related bloodstream inf.	4 Participants n=99 Participants
Relevant medical history Other relevant medical history	161 Participants n=99 Participants
Primary diagnosis for current admission Cardiac	12 Participants n=99 Participants
Primary diagnosis for current admission Trauma	2 Participants n=99 Participants
Primary diagnosis for current admission Neurological	8 Participants n=99 Participants
Primary diagnosis for current admission Infection	42 Participants n=99 Participants
Primary diagnosis for current admission Surgical	29 Participants n=99 Participants
Primary diagnosis for current admission Oncological	328 Participants n=99 Participants
Primary diagnosis for current admission Vascular	4 Participants n=99 Participants
Primary diagnosis for current admission Gastrointestinal	18 Participants n=99 Participants
Primary diagnosis for current admission Other	7 Participants n=99 Participants
Reason for PICC placement Central venous pressure monitoring	2 participants n=99 Participants
Reason for PICC placement Hydration support	20 participants n=99 Participants
Reason for PICC placement Intravenous therapy: immunoglobulins	2 participants n=99 Participants
Reason for PICC placement Intravenous therapy:antimicrobial/antifungal	79 participants n=99 Participants
Reason for PICC placement Intravenous therapy:blood product and transfusion	21 participants n=99 Participants
Reason for PICC placement Intravenous therapy: chemotherapy	313 participants n=99 Participants
Reason for PICC placement Intravenous therapy:pain management	30 participants n=99 Participants
Reason for PICC placement Intravenous therapy: total parenteral nutrition	50 participants n=99 Participants
Reason for PICC placement Intravenous therapy: vasopressors	4 participants n=99 Participants
Reason for PICC placement Limited peripheral access	125 participants n=99 Participants
Reason for PICC placement Nutritional support	15 participants n=99 Participants
Reason for PICC placement Other includes post covid pancreatytis therapy and hypertension IV pharmacotherapy	3 participants n=99 Participants
Reason for PICC placement Serial blood sampling	61 participants n=99 Participants
Reason for PICC placement Serial radiographic studies	3 participants n=99 Participants
Reason for PICC placement Thrombocytopenia or coagulopathy	3 participants n=99 Participants
Intended access duration Long-term (>=30 days)	353 Participants n=99 Participants
Intended access duration Short-term (<30 days)	97 Participants n=99 Participants
Catheter insertion - Location of procedure performance Bedside	190 Participants n=99 Participants
Catheter insertion - Location of procedure performance Interventional radiology	108 Participants n=99 Participants
Catheter insertion - Location of procedure performance Other	152 Participants n=99 Participants
Catheter insertion - Catheter tip repositioning Catheter tip not repositioned	19 Participants n=99 Participants
Catheter insertion - Catheter tip repositioning Catheter tip repositioned	430 Participants n=99 Participants
Catheter insertion - Catheter tip repositioning Missing information - no study device placed	1 Participants n=99 Participants
Catheter insertion - Device placement successful Device placement successful	448 Participants n=99 Participants
Catheter insertion - Device placement successful Device placement unsuccessful	2 Participants n=99 Participants
Catheter insertion - Placement of catheter Right arm	257 Participants n=99 Participants
Catheter insertion - Placement of catheter Left arm	193 Participants n=99 Participants
Catheter insertion - Vein accessed Basilic	253 Participants n=99 Participants
Catheter insertion - Vein accessed Cephalic	15 Participants n=99 Participants
Catheter insertion - Vein accessed Brachial	180 Participants n=99 Participants
Catheter insertion - Vein accessed Other	2 Participants n=99 Participants
Catheter insertion - Vessel/catheter ratio done prior to insertion Vessel/catheter ratio done prior to insertion	272 Participants n=99 Participants
Catheter insertion - Vessel/catheter ratio done prior to insertion Vessel/catheter ratio not done prior to insertion	178 Participants n=99 Participants
Catheter insertion - Number of insertion attempts Number of insertion attempts=1	408 Participants n=99 Participants
Catheter insertion - Number of insertion attempts Number of insertion attempts=2	32 Participants n=99 Participants
Catheter insertion - Number of insertion attempts Number of insertion attempts=3	8 Participants n=99 Participants
Catheter insertion - Number of insertion attempts Number of insertion attempts=4	1 Participants n=99 Participants
Catheter insertion - Number of insertion attempts Number of insertion attempts=5	1 Participants n=99 Participants
Catheter insertion - Local anesthesia used Local anesthesia used	448 Participants n=99 Participants
Catheter insertion - Local anesthesia used Local anesthesia not used	2 Participants n=99 Participants
Catheter insertion - Catheter length trimmed Catheter length trimmed	300 Participants n=99 Participants
Catheter insertion - Catheter length trimmed Catheter length not trimmed	150 Participants n=99 Participants
Catheter insertion - Tunneling used Tunneling used	26 Participants n=99 Participants
Catheter insertion - Tunneling used Tunneling not used	424 Participants n=99 Participants
Catheter insertion - Sherlock TLS used Sherlock TLS used	0 Participants n=99 Participants
Catheter insertion - Sherlock TLS used Sherlock TLS not used	450 Participants n=99 Participants
Catheter insertion - Sherlock 3CG used Sherlock 3CG used	259 Participants n=99 Participants
Catheter insertion - Sherlock 3CG used Sherlock 3CG not used	191 Participants n=99 Participants
Catheter insertion - Method to confirm catheter tip positioning X-ray	157 Participants n=99 Participants
Catheter insertion - Method to confirm catheter tip positioning Sherlock 3CG	202 Participants n=99 Participants
Catheter insertion - Method to confirm catheter tip positioning Other	91 Participants n=99 Participants
Catheter insertion - Stabilization method StatLock	390 Participants n=99 Participants
Catheter insertion - Stabilization method SecurAcath	59 Participants n=99 Participants
Catheter insertion - Stabilization method Missing information - no study device placed	1 Participants n=99 Participants
Catheter insertion - Dressing type Transparent semi-permeable membrane	410 Participants n=99 Participants
Catheter insertion - Dressing type Gauze	10 Participants n=99 Participants
Catheter insertion - Dressing type Other	29 Participants n=99 Participants
Catheter insertion - Dressing type Missing information - no study device placed	1 Participants n=99 Participants
Catheter insertion - PICC insertion as per Instructions For Use (IFUs) PICC inserted as per the IFUs	449 Participants n=99 Participants
Catheter insertion - PICC insertion as per Instructions For Use (IFUs) Missing information - no study device placed	1 Participants n=99 Participants
Catheter insertion - presence of a second implanted line vascular access device Presence of a second implanted line vascular access device	90 Participants n=99 Participants
Catheter insertion - presence of a second implanted line vascular access device No presence of a second implanted line vascular access device	360 Participants n=99 Participants

PRIMARY outcome

Timeframe: from insertion though removal or 180 days, whichever comes first

Population: Since the study device could not be placed in 2 patients and in 1 patient the study device was placed but could not be used for the intended treatment, these 3 subjects were excluded from the denominator for safety variable. Therefore, 447 out of 450 subjects have been considered for denominator calculation.

Incidence of symptomatic venous thrombosis defined as any new occurrence of symptomatic venous thrombosis defined by thrombus presence by ultrasonography or other imaging.

Outcome measures

Outcome measures
Measure	All Subjects n=447 Participants Patients who require the insertion of a device from the BD PowerPICC family according to the clinical practice.
Primary Safety: Incidence of Symptomatic Venous Thrombosis in Patients With a Device From the BD PowerPICC Family Used for Both Short- and Long-term Venous Access.	1.6 % of subjects after PICC placement Interval 0.6 to 3.2

PRIMARY outcome

Timeframe: from insertion though removal or 180 days, whichever comes first

Population: A total of 447 patients received treatment via the study device and were included in the evaluable set, used for the primary performance calculation. The percentage of PICCs that remains in place through the completion of therapy (success) was calculated by dividing successful cases by the total number of devices with non-missing data on success/failure.Therefore, 2 subjects lost to follow-up were not included in the calculation of percentage.

PICCs remaining in place through the required therapy time period were defined as PICCs that were either still in place at the end of the 180-day observation or had been removed because the therapy was completed (end of useful medical use), changed or cancelled. Most patients who died during the study had the device still in place at the time of death and hence were considered as having completed the therapy.

Outcome measures

Outcome measures
Measure	All Subjects n=445 Participants Patients who require the insertion of a device from the BD PowerPICC family according to the clinical practice.
Primary Performance: Percent of PICCs That Remain in Place Through the Required Therapy Time Period.	81.8 % of subjects after PICC placement Interval 77.9 to 85.3

SECONDARY outcome

Timeframe: from insertion though removal or 180 days, whichever comes first

Incidence of phlebitis where phlebitis is defined inflammation of the cannulated vessel identified by redness, swelling, warmth, tenderness, and/or cord formation

Outcome measures

Outcome measures
Measure	All Subjects n=447 Participants Patients who require the insertion of a device from the BD PowerPICC family according to the clinical practice.
Secondary Safety: Incidence of Phlebitis	0 % of subjects after PICC placement Interval 0.0 to 0.8

SECONDARY outcome

Timeframe: from insertion though removal or 180 days, whichever comes first

Incidence of extravasation where extravasation is defined as accidental infiltration of a vesicant or chemotherapeutic drug into the tissue around the catheter

Outcome measures

Outcome measures
Measure	All Subjects n=447 Participants Patients who require the insertion of a device from the BD PowerPICC family according to the clinical practice.
Secondary Safety: Incidence of Extravasation	0 % of subjects after PICC placement Interval 0.0 to 0.8

SECONDARY outcome

Timeframe: from insertion though removal or 180 days, whichever comes first

Incidence of any new occurrence of local infection

Outcome measures

Outcome measures
Measure	All Subjects n=447 Participants Patients who require the insertion of a device from the BD PowerPICC family according to the clinical practice.
Secondary Safety: Incidence of Local Infection	4.5 % of subjects after PICC placement Interval 2.8 to 6.8

SECONDARY outcome

Timeframe: from insertion though removal or 180 days, whichever comes first

Incidence of local infection where local infection is defined as presence of pus at the exit site and/or culture confirmed site infection

Outcome measures

Outcome measures
Measure	All Subjects n=447 Participants Patients who require the insertion of a device from the BD PowerPICC family according to the clinical practice.
Secondary Safety: Incidence of Local Infection as Presence of Pus at the Exit Site and/or Culture Confirmed Site Infection	3.1 % of subjects after PICC placement Interval 2.8 to 6.8

SECONDARY outcome

Timeframe: from insertion though removal or 180 days, whichever comes first

Incidence of Catheter-related bloodstream infection where Catheter-related bloodstream infection is defined as positive blood culture(s) with a microorganism not related to another source (e.g., UTI) OR positive blood culture(s) with microorganism matching catheter tip culture OR blood cultures from peripheral venous puncture and PICC positive with the same microorganism.

Outcome measures

Outcome measures
Measure	All Subjects n=447 Participants Patients who require the insertion of a device from the BD PowerPICC family according to the clinical practice.
Secondary Safety: Incidence of Catheter-related Bloodstream Infection.	1.6 % of subjects after PICC placement Interval 0.6 to 3.2

SECONDARY outcome

Timeframe: from insertion though removal or 180 days, whichever comes first

Incidence of Accidental dislodgement where Accidental dislodgement is defined as catheter accidentally dislodged the extent to which it requires replacement.

Outcome measures

Outcome measures
Measure	All Subjects n=447 Participants Patients who require the insertion of a device from the BD PowerPICC family according to the clinical practice.
Secondary Safety: Incidence of Accidental Dislodgement.	3.8 % of subjects after PICC placement Interval 2.2 to 6.6

SECONDARY outcome

Timeframe: from insertion though removal or 180 days, whichever comes first

Incidence of vessel laceration where vessel laceration is defined as a tear in the tissue of the vessel.

Outcome measures

Outcome measures
Measure	All Subjects n=450 Participants Patients who require the insertion of a device from the BD PowerPICC family according to the clinical practice.
Secondary Safety: Incidence of Vessel Laceration.	0.4 % of subjects after PICC placement Interval 0.1 to 1.6

SECONDARY outcome

Timeframe: from insertion though removal or 180 days, whichever comes first

Incidence of vessel perforation where vessel perforation is defined as a hole formed in the vessel.

Outcome measures

Outcome measures
Measure	All Subjects n=450 Participants Patients who require the insertion of a device from the BD PowerPICC family according to the clinical practice.
Secondary Safety: Incidence of Vessel Perforation.	0.2 % of subjects after PICC placement Interval 0.0 to 1.2

SECONDARY outcome

Timeframe: from insertion though removal or 180 days, whichever comes first

Population: A total of 447 subjects received treatment via the study device and were included in the evaluable set, used for the performance calculation. However, 2 subjects were lost to follow-up and were not included in the calculation of percentage. Patent catheters are defined as functional catheters through therapy.

Percent of patent catheters defined as the number of functional catheters through therapy/total number of catheters.

Outcome measures

Outcome measures
Measure	All Subjects n=445 Participants Patients who require the insertion of a device from the BD PowerPICC family according to the clinical practice.
Secondary Performance: Percent of Patent Catheters	93.9 % of subjects after PICC placement Interval 91.3 to 96.0

SECONDARY outcome

Timeframe: during the insertion procedure

Percent of placement success in single insertion attempt defined as placement success defined as single insertion attempt, proper tip location, and patent catheter

Outcome measures

Outcome measures
Measure	All Subjects n=450 Participants Patients who require the insertion of a device from the BD PowerPICC family according to the clinical practice.
Secondary Performance: Percent of Placement Success in Single Insertion Attempt	90.4 % of subjects after PICC placement Interval 87.3 to 93.0

SECONDARY outcome

Timeframe: during the insertion procedure

Population: The analysis is based on the investigators who completed the questionnaire and answer the respective question.

Ease of insertion determined by composite score of guidewire/stylet performance based on post-insertion survey (5 point Likert scale)

Outcome measures

Outcome measures
Measure	All Subjects n=449 Participants Patients who require the insertion of a device from the BD PowerPICC family according to the clinical practice.
Secondary Performance - Usability: Ease of Insertion Guidewire usage was easy or very easy	419 Participants
Secondary Performance - Usability: Ease of Insertion Force to advance the guidewire acceptable	448 Participants
Secondary Performance - Usability: Ease of Insertion Guidewire withdrawal/removal was easy or very easy	425 Participants
Secondary Performance - Usability: Ease of Insertion Force to withdraw/remove the guidewire acceptable	448 Participants
Secondary Performance - Usability: Ease of Insertion Guidewire integrity	448 Participants
Secondary Performance - Usability: Ease of Insertion Investigators were agree or strongly agree with "Guidewire facilitated placement"	425 Participants
Secondary Performance - Usability: Ease of Insertion Stylet usage was easy or very easy	335 Participants
Secondary Performance - Usability: Ease of Insertion Force to advance the stylet acceptable	352 Participants
Secondary Performance - Usability: Ease of Insertion Stylet withdrawal/removal was easy or very easy	343 Participants
Secondary Performance - Usability: Ease of Insertion Force to withdraw/remove the stylet acceptable	353 Participants
Secondary Performance - Usability: Ease of Insertion Stylet integrity	356 Participants
Secondary Performance - Usability: Ease of Insertion Investigators were agree or strongly agree with "Stylet facilitated placement"	338 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: during the insertion procedure

Population: The analysis is based on the investigators who completed the questionnaire and answer the respective question.

The percentage of Sherlock 3CG Pre-Loaded Stylet that aided in guidance and placement of the catheter, when used

Outcome measures

Outcome measures
Measure	All Subjects n=259 Participants Patients who require the insertion of a device from the BD PowerPICC family according to the clinical practice.
Usability: Ease of Insertion When the Sherlock 3CG Pre-Loaded Stylet Used	244 Participants

POST_HOC outcome

Timeframe: from insertion though removal or 180 days, whichever comes first

Population: The overall mean device lifetime

Post-hoc analysis: overall mean device lifetime

Outcome measures

Outcome measures
Measure	All Subjects n=450 Participants Patients who require the insertion of a device from the BD PowerPICC family according to the clinical practice.
Post-hoc Analysis: Device Lifetime	90.64 days Standard Deviation 68.41

Adverse Events

All Subjects

Serious events: 58 serious events

Other events: 162 other events

Deaths: 32 deaths

Serious adverse events

Serious adverse events
Measure	All Subjects n=450 participants at risk Patients who received a device from the BD PowerPICC family according to the clinical practice.
Blood and lymphatic system disorders Febrile neutropenia	1.1% 5/450 • Number of events 5 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Cardiac disorders Cardiac failure	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Cardiac disorders Cardiopulmonary failure	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Gastrointestinal disorders Constipation	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Gastrointestinal disorders Ileal stenosis	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Gastrointestinal disorders Nausea	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Gastrointestinal disorders Stomatitis	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Pyrexia	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Hepatobiliary disorders Cholecystitis acute	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Bacteraemia	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations COVID-19	0.44% 2/450 • Number of events 2 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations COVID-19 pneumonia	0.89% 4/450 • Number of events 4 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Catheter bacteraemia	0.67% 3/450 • Number of events 3 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Catheter site infection	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Pneumonia	0.44% 2/450 • Number of events 2 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Septic shock	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Subdiaphragmatic abscess	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Urinary tract infection	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Metabolism and nutrition disorders Electrolyte imbalance	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.67% 3/450 • Number of events 3 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Germ cell cancer metastatic	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.89% 4/450 • Number of events 4 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurofibrosarcoma	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.44% 2/450 • Number of events 2 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer metastatic	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue cancer metastatic	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Nervous system disorders Haemorrhagic stroke	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Nervous system disorders Ischaemic stroke	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Product Issues Device breakage	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Renal and urinary disorders Acute kidney injury	0.22% 1/450 • Number of events 3 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.44% 2/450 • Number of events 3 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.89% 4/450 • Number of events 4 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.

Other adverse events

Other adverse events
Measure	All Subjects n=450 participants at risk Patients who received a device from the BD PowerPICC family according to the clinical practice.
Blood and lymphatic system disorders Febrile neutropenia	1.1% 5/450 • Number of events 5 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Cardiac disorders Cardiac failure	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Cardiac disorders Cardiopulmonary failure	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Gastrointestinal disorders Constipation	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Gastrointestinal disorders Enteritis	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Gastrointestinal disorders Ileal stenosis	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Gastrointestinal disorders Nausea	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Gastrointestinal disorders Stomatitis	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Catheter site discharge	1.1% 5/450 • Number of events 5 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Catheter site dryness	0.44% 2/450 • Number of events 2 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Catheter site erythema	5.3% 24/450 • Number of events 26 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Catheter site exfoliation	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Catheter site granuloma	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Catheter site haematoma	0.67% 3/450 • Number of events 3 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Catheter site haemorrhage	1.8% 8/450 • Number of events 8 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Catheter site hypersensitivity	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Catheter site irritation	0.44% 2/450 • Number of events 2 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Catheter site necrosis	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Catheter site edema	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Catheter site pain	1.8% 8/450 • Number of events 9 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Catheter site pruritus	0.44% 2/450 • Number of events 2 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Catheter site related reaction	0.44% 2/450 • Number of events 2 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Catheter site thrombosis	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Catheter site vesicles	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Complication of device remova	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Device related thrombosis	3.6% 16/450 • Number of events 16 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Peripheral swelling	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Pyrexia	0.89% 4/450 • Number of events 4 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Sensation of foreign body	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
General disorders Vessel puncture site injury	0.44% 2/450 • Number of events 2 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Hepatobiliary disorders Cholecystitis acute	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Abscess limb	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Bacteraemia	0.67% 3/450 • Number of events 3 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations COVID-19	0.44% 2/450 • Number of events 2 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations COVID-19 pneumonia	0.89% 4/450 • Number of events 4 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Catheter bacteraemia	1.6% 7/450 • Number of events 7 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Catheter site infection	4.0% 18/450 • Number of events 19 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Device related infection	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Enterococcal bacteraemia	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Pneumonia	0.44% 2/450 • Number of events 2 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Septic shock	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Staphylococcal sepsis	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Subdiaphragmatic abscess	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Infections and infestations Urinary tract infection	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Injury, poisoning and procedural complications Rib fracture	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Injury, poisoning and procedural complications Skin injury	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Metabolism and nutrition disorders Electrolyte imbalance	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Musculoskeletal and connective tissue disorders Pathological fracture	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.67% 3/450 • Number of events 3 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Germ cell cancer metastatic	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.89% 4/450 • Number of events 4 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neurofibrosarcoma	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.44% 2/450 • Number of events 2 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer metastatic	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tongue cancer metastatic	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Nervous system disorders Haemorrhagic stroke	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Nervous system disorders Ischaemic stroke	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Product Issues Device breakage	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Product Issues Device dislocation	3.8% 17/450 • Number of events 17 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Product Issues Device occlusion	1.1% 5/450 • Number of events 7 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Renal and urinary disorders Acute kidney injury	0.22% 1/450 • Number of events 3 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.44% 2/450 • Number of events 3 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.1% 5/450 • Number of events 5 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Skin and subcutaneous tissue disorders Dermatitis contact	3.8% 17/450 • Number of events 21 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Skin and subcutaneous tissue disorders Rash	0.44% 2/450 • Number of events 2 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Surgical and medical procedures Oesophageal operation	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.
Vascular disorders Venous perforation	0.22% 1/450 • Number of events 1 • From PICC insertion though removal or 180 days, whichever comes first An AE is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device. An adverse device effect is defined as any adverse event that is considered to be related to the use of an investigational medical device.

Additional Information

Clinical Project Manager

Becton, Dickinson and Company

Phone: 00393452237718

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI submits to Sponsor for review a draft 90 days prior to submission of the draft for publication.Draft shall not divulge any confidential info.Sponsor has the right to:review and make comments on any proposed publication; withhold the use of its name in connection with publication;make any results from the study known to its customers and governmental agencies prior to publication.The first publication of the study results shall be made in conjunction with the results from the other PIs.
Publication restrictions are in place

Restriction type: OTHER