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

Model Number	N/A
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2025, the doctor made rounds to assess the need for bedside crrt treatment, and femoral vein crrt catheterization was performed.At 09:30 on (b)(6) 2025, the ultrasound was guided in real time, the anesthesia was satisfactory, the puncture positioning was carried out smoothly, and the dark red blood could be successfully withdrawn, but in the guide wire feeding link, the guide wire was extremely unsmooth, in order to avoid vascular damage to the patient, the puncture needle was pulled out together with the guidewire, and local pressure was applied to stop the bleeding.Later, it was found that the guidewire was embedded in the needle tube and could not move forward or backward.Considering the mismatch between the guidewire and the needle tube, the crrt puncture package is reopened, the guidewire is matched with the needle tube, the puncture is smooth, and the patient can proceed with crrt treatment smoothly.This event caused the patient to undergo a second puncture, resulting in local vascular damage.No further information was provided.
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 device has not been received by the manufacturer for evaluation.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.

• Brand Name: NIAGARA
• 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: 23646668
• Report Number: 3006260740-2025-09036
• Device Sequence Number: 11987788
• Product Code: MPB
• UDI-Device Identifier: 00801741045585
• UDI-Public: (01)00801741045585(11)241228(17)270930(10)REJX2156
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2025

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: 5593240
• Device Lot Number: REJX2156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/28/2024
• 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