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

Catalog Number	10302804
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The national competent authority for medical device problems, basg, of austria notified angiodynamics of an event that occurred with a bioflo duramax dialysis catheter.The end user reported there was a spontaneous leak between the adapter and the tubing.A number of cases have already occurred in vienna.It is reasonable to conclude the catheter was removed due to this issue.
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
Returned was one (1) 28cm bioflo dialysis catheter (dc).Device appeared used and contaminated with bio-material.A fracture/leak of the arterial extension leg tubing was observed, confirming the reported complaint description.The fracture was located right at the junction between the luer hub and the extension leg tubing; see attached picture.There were no noted defects/cracks noted to the luer hub itself or any other damage to the dc device.Root cause for this type and location of the failure mode observed is due to over-torquing of the extension leg tubing-to-luer hub junction during cleaning/care and maintenance, i.E.Grasping the extension leg tubing rather than luer hub itself.This is supported by information that device was accessed 3x a week for 9.5 months.The customer's complaint description is confirmed for leak near the luer hub.There is a fracture/hole of the extension tube adjacent to the hub luer.There are no visible indications that the failure is related to either the manufacturing process or associated tooling.Root cause for this type and location of the failure mode observed is due to over-torquing of the extension leg tubing-to-luer hub junction during cleaning/care and maintenance, i.E.Grasping the extension leg tubing rather than luer hub itself.In lieu of a reported lot number, a shr was generated for item number (h965103028041) in order to ascertain the last three lots shipped to the reporting customer in the six (6) months prior to the procedure date.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the following is provided as a reference from dfu: use only luer lock (threaded) connectors with this catheter.Scrub catheter luer lock connectors with an appropriate antiseptic after cap is removed and before accessing.Perform every time catheter is accessed or disconnected.If luer lock connectors are cleansed with a cleansing solution, allow the solution to dry fully before applying catheter end caps.Tape end caps between treatments to safeguard them against accidental removal.Close the extension clamps, remove the syringes, and place an injection cap on each luer lock connector.Avoid air embolism by keeping extension tubing clamped at all times when not in use and by aspirating then irrigating the catheter with saline prior to each use.With each change in tubing connections, purge air from the catheter and all connecting tubing and caps.Reference (b)(4).

• Brand Name: BIOFLO DIALYSIS CATHETER
• Common Device Name: 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: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 17765989
• Report Number: 1317056-2023-00126
• Device Sequence Number: 20606415
• Product Code: MSD
• UDI-Device Identifier: H965103028041
• UDI-Public: H965103028041
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K131260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 10302804
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown