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

Model Number N/A

Device Problems Disconnection (1171); Air/Gas in Device (4062)

Patient Problem Blood Loss (2597)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that : the service declares that three identical incidents occurred on three different patients, observed by three different paramedical personnel, at the level of the entry route of the dialysis set.It was noted the unscrewing between the dialysis catheter and the dialysis set, at the level of the screw closest to the patient (entry port).For each of the three incidents, it had no direct consequence; however, air entered the dialysis set which caused the dialysis to be stopped.The recovery of the blood volume was impossible.The risk of gas embolism is major, as well as significant blood loss from the catheter.The offending devices were not kept at the service level.Also the references of the catheters and the lot numbers (dialysis catheter) are not identified.This report addresses the third catheter/patient.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 10829862
• MDR Text Key: 217455171
• Report Number: 3006260740-2020-20484
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2020

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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