MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 5F TL MB+KIT W/BIOPATCH PC BELDARNG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reez3883 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported a wire has a defect.It broke when trying to advance.Wire appeared to be frayed.Add info rcvd 5/13/2021: it was reported that the nurse had trouble threading picc through shoulder area.When he pulled the picc out of the patient for investigation the wire was hanging out of the tip of the picc and when pulled on, a piece came out that had broken off.
Event or Problem Description
It was reported a wire has a defect.It broke when trying to advance.Wire appeared to be frayed.Add info rcvd 5/13/2021: it was reported that the nurse had trouble threading picc through shoulder area.When he pulled the picc out of the patient for investigation the wire was hanging out of the tip of the picc and when pulled on, a piece came out that had broken off.
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 damaged stylet is confirmed; however, the exact cause is unknown.One 3cg stylet and one 5 fr triple lumen powerpicc solo catheter were returned for evaluation.An initial visual observation showed use residue on the returned samples.The stylet was found to be broken into two pieces approximately 4.4 cm proximal to its distal tip.Multiple bends and kinks were observed in the returned stylet.The stylet was observed to be completely removed from the t-lock.The epoxy tip of the stylet was observed to be returned.A microscopic observation revealed the break in the polyimide tubing was uneven with a rough surface texture and plastic deformation.The core wire was observed to protrude from the proximal break site and the break in the core wire was observed to be tapered, suggesting a tensile failure.Many kinks were observed in the polyimide tubing and were each found to be between magnet interfaces.A magnet at the break site was observed to be broken.The observed fracture features were indicative of catheter and/or stylet kinking, which likely occurred during the insertion process.However, the exact circumstances providing for that type of event were ultimately unknown.H3 other text : evaluation findings are in section h.11.

• Brand Name: POWERPICC PROVENA SOLO 5F TL MB+KIT W/BIOPATCH PC BELDARNG
• 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: 11932330
• Report Number: 3006260740-2021-02141
• Device Sequence Number: 17265964
• Product Code: LJS
• UDI-Device Identifier: 00801741155222
• UDI-Public: (01)00801741155222
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• 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): 07/06/2021

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: N/A
• Device Catalogue Number: S1395108D5
• Device Lot Number: REEZ3883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 08/05/2021
• 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