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

Catalog Number	5593200
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
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.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.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported that the patient was admitted to icu due to sepsis.As the patient's condition was serious and needed hemodialysis treatment, the doctor used the catheter to place it into the right femoral vein for the patient at the bedside at 13:30, and the guidewire was not smooth when he pulled it out after placing the catheter.After repeatedly adjusting the position and pulling it out, he found that the guidewire had been folded inside the body, and then he immediately replaced this catheter and relocated the catheter to carry out the next step of the treatment for the patient.The patient's condition will be monitored continuously.There were no pieces retained in the patient and no intervention required.No further information provided.

• 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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21915522
• Report Number: 3006260740-2025-02616
• Device Sequence Number: 14508503
• Product Code: MPB
• UDI-Device Identifier: 00801741045578
• UDI-Public: (01)00801741045578(11)230226(17)260131(10)REHP1053
• 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): 04/11/2025

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: 01/31/2026
• Device Catalogue Number: 5593200
• Device Lot Number: REHP1053
• 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: 04/08/2025
• Initial Report FDA Received Date: 04/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2023
• 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