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

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	11/19/2025
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 complaint of a stuck guidewire is confirmed; however, the exact cause is unknown.One video of a guidewire and an 18g introducer needle was returned for evaluation.An initial visual observation of the video showed a guidewire inserted into an 18g introducer needle.A small portion of the distal end of the guidewire was observed to be protruding from the distal tip of the introducer needle.A clinician attempted to advance and retract guidewire, which revealed the guidewire was stuck within the introducer needle.During attempted retraction, the proximal end of the guidewire was observed to elongate.Blood residue was observed on the guidewire in the returned video.While the guidewire was confirmed to be stuck within the introducer needle, the exact root cause could not be determined.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported the guide wire is irreversibly stuck in the puncture needle.No patient injury was reported.(b)(6) 2025- it was found during an investigation the proximal end of the guidewire was observed to elongate.

• Brand Name: NIAGARA SLIM-CATH
• 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: becky sparks ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23983305
• Report Number: 3006260740-2025-10250
• Device Sequence Number: 10609112
• Product Code: MPB
• UDI-Device Identifier: 00801741045363
• UDI-Public: (01)00801741045363(11)250528(17)280331(10)REKR0901
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 12/31/2025

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 Model Number: N/A
• Device Catalogue Number: 5553200
• Device Lot Number: REKR0901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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