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 No Patient Involvement (2645)

Event Date 06/08/2020

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 redw0139 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported that the distal end of the blue lumen was broken after opening the package prior to use.

• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 10218942
• MDR Text Key: 197745848
• Report Number: 3006260740-2020-02317
• 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
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/01/2020

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: 08/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 5593200
• Device Lot Number: REDW0139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2019
• 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