MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM (PRE-CURVED); CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problem Material Twisted/Bent (2981)

Patient Problem Pain (1994)

Event Date 04/30/2022

Event Type  malfunction  

Event Description

It was reported the patient was admitted to the hospital due to abdominal pain for 10 hours.In order to carry out blood purification treatment smoothly, femoral vein puncture was performed at 21:30 on (b)(6) 2022.During the operation, the guide wire was bent in many places, resulting in the failure of the dialysis catheter to penetrate the femoral vein smoothly.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reex2166 showed no other similar product complaint(s) from this lot number.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM (PRE-CURVED)
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• 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 olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14518729
• MDR Text Key: 292792685
• Report Number: 3006260740-2022-01976
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045608
• UDI-Public: (01)00801741045608
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K090102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2022

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5594150
• Device Lot Number: REEX2166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other