MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA SLIM-CATH 15 CM PRE-CURVE KIT; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problem Failure to Infuse (2340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of recx2878 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that after the crrt treatment of the patient on may 21, 2020, the machine alarmed "no flow in the blood line" and the machine was withdrawn.Replacing the same batch of the same model dialysis catheter, crrt treatment proceeded smoothly.

• Brand Name: NIAGARA SLIM-CATH 15 CM PRE-CURVE KIT
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 10176710
• MDR Text Key: 200014990
• Report Number: 3006260740-2020-02159
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045394
• UDI-Public: (01)00801741045394
• Combination Product (y/n): N
• PMA/PMN Number: K010778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/19/2020

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 Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 5554150
• Device Lot Number: RECX2878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• 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