MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERTRIALYSIS, PC EXTENSION LEGS; ACUTE DIALYSIS CATHETER

Model Number	N/A
Medical Device Problem Codes	Component Incompatible (1108); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2025
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by customer that the central ir had a 13f x 15cm trialysis catheter malfunction over the weekend where the wire got stuck in the patient and was hard to pull out.The team ended up not using the catheter on the patient so there was no harm to the patient at all.
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 a guidewire not threading through the catheter was confirmed and determined to be manufacturing related.13 fr x 15 cm trialysis catheter and one 0.035 in.J-tip guidewire were returned for evaluation.The returned unit was functionally tested by attempting to thread the returned guidewire through the purple lumen of the catheter.During testing, the guidewire encountered resistance near the tip of the catheter.A cross-section of the catheter was taken at the location where the guidewire encountered resistance.A measurement was then taken of the inner diameter at the cross-section location.The diameter was found to be smaller than the outer diameter of the 0.035in.Guidewire, indicating that the catheter dimensions were out of specification.This defect likely occurred during the tipping process at the manufacturing facility.

• Brand Name: POWERTRIALYSIS, PC EXTENSION LEGS
• Common Device Name: ACUTE DIALYSIS CATHETER
• 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: carey carter ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21552147
• Report Number: 3006260740-2025-01316
• Device Sequence Number: 8180108
• Product Code: NIE
• UDI-Device Identifier: 00801741041945
• UDI-Public: (01)00801741041945(11)240701(17)260228(10)REJT1659
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 5613150
• Device Lot Number: REJT1659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2024
• 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 Sex: Unknown