MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH DIALYSIS 12FX20CM; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reds3571 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reds3571) have been reported from the same facility in (b)(6).Device not returned for evaluation.

Event Description

It was reported that when using the product, the air leaked when the blood was drawn back with the syringe, and the connector was broken when the syringe was connected, and the blood could not be drawn.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS 12FX20CM
• 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: 11172860
• MDR Text Key: 228213408
• Report Number: 3006260740-2020-21321
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045363
• UDI-Public: (01)00801741045363
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K010778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2020

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: 5553200
• Device Lot Number: REDS3571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• 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
• Patient Outcome(s): Other