MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO / ANGIODYNAMICS; DIALYSIS CATHETER

Catalog Number H965103038031

Device Problems Air Leak (1008); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/24/2016

Event Type  malfunction  

Manufacturer Narrative

Although the used catheter has been returned to angiodynamics, the device evaluation has not yet been conducted.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Event Description

As reported dialysis catheter had been placed in the patient's right ij on (b)(6) 2016.There were no complications during insertion and the patient, on home hemodialysis, had not had any issues intil the night of (b)(6) 2016, when her circuit filled with air.A hole was confirmed when the patient came in for assessment and the line was replaced.The patient condition was reported to be "unaffected" by the event.The used device is expected to be returned to angiodynamics for evaluation.

Manufacturer Narrative

The angiodynamics (b)(6) 2016 complaint report was reviewed for the bioflo dialysis product family and the failure mode, " extension leg detached/separated/fractured." no adverse trend was indicated.Returned was a used catheter which was confirmed to have a hole in the venous extension tube just below the junction with the female luer.There was no visible indication that the failure is related to either the manufacturing process or the associated tooling.As a definitive root cause for this event could not be determined, a capa has been initiated to provide further investigation and determine if corrective action is required.Manufacturing process controls for the dialysis catheter include visual inspection for damage or defects.100% leak testing, and guidewire insertion testing to verify lumen patency.(b)(4).

• Brand Name: BIOFLO / ANGIODYNAMICS
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 6187086
• MDR Text Key: 62789883
• Report Number: 1317056-2016-00186
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: H965103038031
• UDI-Public: H965103038031
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: H965103038031
• Device Lot Number: 4888102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2015
• 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