MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIMCATH; ACUTE DIALYSIS CATHETER

Model Number	N/A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer, during an emergency procedure the catheter insertion guide bent, making it difficult to insert the device.Additional information: it was reported there was no serious damage, but it was necessary to repeat the medical procedure of inserting a new dialysis catheter.There were no changes to the treatment, only a slowdown in the procedure.01/28/2025 - during evaluation of the returned guidewire, some core wire weakness was observed at the proximal end.
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 bent guidewire is confirmed, but the exact cause could not be determined.One 0.038 in.J-tip guidewire was returned for evaluation.An initial visual observation of the returned guidewire showed little use residues throughout the returned sample.A slight bend was observed along the length of the guidewire.The guidewire was observed to be curved, and the j-tip was observed to have less curvature than its original design.A tactile evaluation of the returned guidewire revealed some core wire weakness observed at the proximal end of the guidewire.The guidewire felt like it was clicking into place and floppy.A root cause of this failure could not be determined due to the device being used, as handling or other unknown factors may have contributed to the device failure.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: NIAGARA SLIMCATH
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21462378
• Report Number: 3006260740-2025-00968
• Device Sequence Number: 12708121
• Product Code: MPB
• UDI-Device Identifier: 00801741045370
• UDI-Public: (01)00801741045370(11)230112(17)250430(10)REGV3544
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K010778
• 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
• Report Date (Section B): 02/25/2025

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: 04/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 5553240
• Device Lot Number: REGV3544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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 Sex: Unknown