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

Catalog Number H965103038041

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

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

Event Date 03/14/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records was performed for the indicated 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.The recent angiodynamics complaint report was reviewed for the bioflo dialysis product family and the failure mode "extension leg - detached/separated/fractured." no adverse trend was identified.The used bioflo dialysis catheter was returned to angiodynamics for evaluation.As received, it was noted during the visual inspection that there was a hole just below the female luer {red clamp side}.Thus the reported complaint device failure mode of "hole noted in extension tubing near hub junction was confirmed." the hole was observed in the arterial extension tube adjacent to the flat section of the hub, i.E.90° from the parting line.Although the complaint has been confirmed, there are no visible indications that the failure is related to either the manufacturing process or associated tooling.A potential root cause for this failure is over-torqueing of the hub-to-extension tubing junction during cleaning/use of the device, which has been in place since 2017.The directions for use provided with the device contain the following warnings: "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.".((b)(4)).

Event Description

As reported by end user hospital in (b)(6), a pinhole was discovered on the arterial connection port of a bioflo dialysis catheter.It was leaking blood.The catheter had been placed on (b)(6) 2017 and was removed on (b)(6) 2019.The used device was returned to angiodynamics.There was no reported patient injury or complications.

• Brand Name: ANGIODYNAMICS / BIOFLO
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• 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
• MDR Report Key: 8583902
• MDR Text Key: 145746201
• Report Number: 1317056-2019-00065
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: H965103038041
• UDI-Public: H965103038041
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: H965103038041
• Device Lot Number: 5151194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2017
• 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