MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 3F SL MBPLUS 3CG BIOPATCH PC BELDAR NG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint of a damaged introducer sheath is confirmed; however, the exact cause is unknown.One 3.5 fr x 7 cm microintroducer assembly was returned for evaluation.An initial visual observation showed use residue on the returned sample.The distal tip of the introducer sheath was observed to be damaged.A microscopic observation revealed one edge of the distal tip of the introducer sheath was buckled and folded inward upon itself.The corners of this folded point were observed to be plastically deformed and torn slightly.While the root cause of the damage observed on the introducer sheath is unknown, possible causes include damage during handling or use.A lot history review (lhr) of reew3038 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported an introducer bunching up.We had to use the introducer from the microintroducer kit to complete line insertion.This resulted in bleeding at the site where pressure had to held for 5-10 minutes before dressing could be applied.We were placing a single lumen at the time.Add info rcvd 01/25/2021: unable to use product after first attempt, product secured, introducer from microintroducer kit used to place line.No patient harm was noted or reported, pressure had to be held at site for greater than 10 min before dressing could be applied.

• Brand Name: POWERPICC PROVENA 3F SL MBPLUS 3CG BIOPATCH PC BELDAR NG
• 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: 11960301
• Report Number: 3006260740-2021-02223
• Device Sequence Number: 1403417
• Product Code: LJS
• UDI-Device Identifier: 00801741155130
• UDI-Public: (01)00801741155130
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• 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): 05/24/2021

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: S1173108D5
• Device Lot Number: REEW3038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 06/08/2021
• 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
• Patient Age: 62 YR