MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number H965103028031

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).

Event Description

As reported: angiodynamics' distributor received a medical device vigilance form reference 2019/010/025/401/007 from mhra.Per the mdv received: patient attend a & e with double lumen device snap/detach from catheter line.There was no report af patient harm or injury due to this event.The reported defective disposable device has been returned to the manufacturer for evaluation.

Manufacturer Narrative

Received one {1} bioflo dialysis catheter in a plastic bag.As received, the catheter was returned in two pieces and it was noted the catheter shaft was detached.It was also noted during the disinfection process that the arterial side of the catheter shaft was occluded with bio material {blood clots} inside.After the cleaning process, no difficulty was noted when flushing each side of the catheter shaft.The complaint description of "suture wing detach from the catheter line" appears to have been caused by something cutting the catheter.The separation is very clean with no sign of stretching or degradation of the catheter shaft.No manufacturing non-conformances were observed during the sample review.The reported complaint description is confirmed as the suture wing was not attached to the catheter, however, the root cause for the event was determined to be due to user handling of the device.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: the following is provided as a reference from the dfu for this product warnings in the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism and remove catheter.Use of excessive pull force on the catheter may cause the suture wing to detach from the bifurcate.Do not use acetone on any part of the catheter tubing.Exposure to this agent may cause catheter damage.Do not use sharp instruments near the extension tubing or catheter lumen.Do not use scissors to remove dressing.Catheter will be damaged if clamps other than what is provided with this kit are used.Clamping of the tubing repeatedly in the same location may weaken tubing.Avoid clamping near the luers and hub of the catheter.Examine catheter lumen and extensions before and after each treatment for damage.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).

• Brand Name: BIOFLO DIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 9375997
• MDR Text Key: 198786075
• Report Number: 1317056-2019-00150
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: H965103028031
• UDI-Public: H965103028031
• Combination Product (y/n): N
• PMA/PMN Number: K131260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: H965103028031
• Device Lot Number: 5380731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Date Manufacturer Received: 11/12/2019
• Patient Sequence Number: 1