MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 5F TL; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	S1385108D4
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reeu1417 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported after placing picc and removing the 3cg stylet wire, clinician saw the wire was kinked near the distal end.Clinician claimed there was resistance threading the picc and had to move the picc back and forth to eventually get the catheter in the optimal place.Additional information received: it was reported the guidewire broke in two while trying to insert into patient.
Event or Problem Description
It was reported after placing picc and removing the 3cg stylet wire, clincian saw the wire was kinked near the distal end.Clinician claimed there was resistance threading the picc and had to move the picc back and forth to eventually get the catheter in the optimal place.Additional information received: it was reported the guidewire broke in two while trying to insert into patient.
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: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a broken stylet is confirmed; however, the exact cause is unknown.One 3cg stylet within a t-lock was returned for evaluation.An initial visual observation showed use residue on the returned sample.The stylet was observed to be broken and was returned in two pieces.The stylet was also observed to be bent slightly near its distal tip.A microscopic observation revealed plastic deformation in the polyimide tubing at the location of the break.The break site of the core wire of the stylet was slightly curved and was observed to taper, suggesting the break was caused by excessive tensile (pulling) force.While the exact cause of the break in the returned stylet is unknown, possible causes include excessive manipulation of the stylet prior to or during placement and advancement/retraction of stylet against resistance.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC PROVENA 5F TL
• 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: 10876411
• Report Number: 3006260740-2020-20596
• Device Sequence Number: 11452658
• Product Code: LJS
• UDI-Device Identifier: 00801741155079
• UDI-Public: (01)00801741155079
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: S1385108D4
• Device Catalogue Number: S1385108D4
• Device Lot Number: REEU1417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 02/11/2021
• 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: Other