MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of complications during the insertion process was confirmed.One unraveled guidewire was received within an introducer needle.A break was observed in the coiled end of the guidewire, which allowed the coil wire to stretch and unravel over the core wire.The outside diameter of the guidewire was within specification.The inner edge of the needle bevel exhibited deformation, which is consistent with the guidewire being retracted through the needle.The instructions for use (ifu) caution, ¿if the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.¿ no damage associated with the manufacturing process was observed on the returned sample.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that during catheter insertion, the catheter was found difficult to insert.After removal, the wire and catheter were found deformed.(b)(6) 2022- the returned guidewire was broken.

• Brand Name: POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 13764981
• Report Number: 3006260740-2022-00793
• Device Sequence Number: 17409052
• Product Code: LJS
• UDI-Device Identifier: 00801741027932
• UDI-Public: (01)00801741027932
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2022

1 Device 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: 3275155
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial