MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 4F SL MAX BARRIER PLUS KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reew4343 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "4 french single lumen picc wire broke off inside patient when inserting today.Patient had to be taken to ir for surgical retrieval." add info rcvd 03/08/2021: placement info: left brachial vein.Was there patient harm reported?: patient required extraction of the broken device, but significant harm noted.What they¿re being treated for: admitted for fall.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: returned sample(s), patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken 3cg stylet wire was confirmed but the exact cause was unknown.Two photographs were submitted for evaluation.Both contained images of a 3cg stylet but only one was focused on the distal stylet tip.A review of that imaged confirmed that a permanent kink existed near the distal stylet tip and no conductive tip could be seen at the tip which suggested a segment of wire was missing.That potential detached segment was not visible in either image.The lack of focus in the image prevented further observation and no other potentially relevant information was visible.While the complaint could be confirmed with the provided image, the potential root cause of that event could not be determined with the provided image.Further evaluation will be performed if the implicated sample is returned for evaluation.
Event or Problem Description
It was reported "4 french single lumen picc wire broke off inside patient when inserting today.Patient had to be taken to ir for surgical retrieval." add info received 03/08/2021: placement info: left brachial vein was there patient harm reported?: patient required extraction of the broken device, but significant harm noted what they are being treated for: admitted for fall.

• Brand Name: POWERPICC 4F SL MAX BARRIER PLUS KIT
• 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: 11575530
• Report Number: 3006260740-2021-00991
• Device Sequence Number: 19697922
• Product Code: LJS
• UDI-Device Identifier: 00801741154836
• UDI-Public: (01)00801741154836
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• 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,Followup
• Report Date (Section B): 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1174108D2
• Device Lot Number: REEW4343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 05/21/2021
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 46