MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV 3F SL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	3173108
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reer3361 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by health professional "friday i was in the or about to insert a 3fr.Single lumen powerpicc sv catheter on a patient.The vein was already accessed, and the microez(tm) microintroducer with vessel dilator were already threaded/ dilated into the vessel, and closed off with the clear end cap.The catheter was first flushed through while remaining in the original packaging to prime the lumen and line, but now was removed from packaging for insertion.The problem began, when i went to slightly remove the internal stiffening stylet (iss) to allow for tip trimming per patient requirements.The iss automatically felt different, difficult to pull back from the luer-lock end of the lumen.Immediately looking to the tip of the untrimmed catheter, the iss was somehow adhered to the inside of the catheter lumen, almost resistant to being removed- only at the untrimmed tip of the catheter (approx from 40cm markings all the way to the 45cm markings; total length of catheter being 45cm).As the catheter had previously been flushed/ primed i cannot think of another reason for this to happen.The patient required almost the entire length of the catheter from previous measurements, so i couldn't simply trim and insert.When the iss finally relinquished the inside of the catheter, i noted three tiny sheer markings to the outside of the catheter- which ultimately made my initial thought a reality- to obtain an entirely new picc line from central supply.This all happened relatively quick as the vessel had already been accessed/dilated and awaiting threading of catheter, not to mention the patient was under sedation.".

• Brand Name: POWERPICC SV 3F SL
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10901084
• Report Number: 3006260740-2020-20655
• Device Sequence Number: 10899088
• Product Code: LJS
• UDI-Device Identifier: 00801741027529
• UDI-Public: (01)00801741027529
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3173108
• Device Catalogue Number: 3173108
• Device Lot Number: REER3361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other