MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA DIALYSIS CATHETER KIT 13.5F X 20CM (SHORT-TERM) (DUAL-LUMEN); CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redp4249 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the patient was admitted to hospital due to "organophosphorus pesticide poisoning".Patient entered the icu at 16:40, give icu nursing routines, and give ecg monitoring at the bedside.The patient was given bedside perfusion treatment at 17:05 on (b)(6) 2020, and the hemodialysis line was found during the operation of the machine.The blood leaked from the reinfusion end and continued to leak.After reporting to the doctor, the hemoperfusion treatment was terminated.The puncture tube has been removed.The consequence for the patient is blood loss, about 50 ml.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 20CM (SHORT-TERM) (DUAL-LUMEN)
• 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: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 10581995
• MDR Text Key: 208578342
• Report Number: 3006260740-2020-03354
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045578
• UDI-Public: (01)00801741045578
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030268
• 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: 09/24/2020

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: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 5593200
• Device Lot Number: REDP4249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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