MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER-TRIALYSIS SHORT-TERM CURVED DIALYSIS CATHETER (13F) (15CM) (TL); CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2023
Type of Reportable Event	Malfunction
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 complaint of difficulty inserting a guidewire is confirmed.One 0.035 in.J-tip guidewire in a plastic hoop and one 18 g secureloc introducer needle were returned for evaluation.An initial visual observation showed use residue on the returned sample.While the guidewire was returned in the introducer needle, it was not found to be stuck.The core wire of the guidewire was found to not be broken during tactile evaluation.A microscopic observation revealed the bevel of the introducer needle was damaged.A relatively large amount of dried blood residue was observed on the returned guidewire, especially on the section of guidewire that was within the introducer needle.This biological material may have contributed to the alleged event of the guidewire becoming stuck within the introducer needle.One of the coils of the coiled wire of the guidewire was found to be unraveled near the distal end of the guidewire; however, no other damage was observed on the returned guidewire.Normal movement of the guidewire is away from the sharpened bevel and will not damage the wire.If the guidewire direction is reversed, the guidewire is then pulled against the sharpened edge of the needle bevel and can cause shearing damage of the wire and/or cause the wire to become stuck within the needle.The needle deformation was consistent with guidewire retraction against the needle bevel.H3 other text : evaluation findings are in section h11.
Event or Problem Description
Per medwatch: guidewire became stuck in needle during short term trial catheter insertion.Additional information received 02/28/2023: guidewire was used during an insertion of a trial catheter for a patient, it became stuck in needle during catheter insertion.No patient harm reported.(b)(6) 2023 one of the coils of the coiled wire of the guidewire was found to be unraveled near the distal end of the guidewire.

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED DIALYSIS CATHETER (13F) (15CM) (TL)
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16856817
• Report Number: 3006260740-2023-01664
• Device Sequence Number: 8528428
• Product Code: NIE
• UDI-Device Identifier: 00801741075094
• UDI-Public: (01)00801741075094
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2023

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 Expiration Date: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 5615150
• Device Lot Number: REGY2189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female