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

Model Number	02-803
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	01/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference: (b)(4).
Event or Problem Description
Merit medical notified angiodynamics of a complaint received from an end user regarding a bioflo chronic dialysis catheter 15.5f 24cm duramax kit.The customer reports the device was leaking.It was reported the device is available for return ( was removed).No further information was able to be provided.
Additional Manufacturer Narrative
Received one (1) bioflo dialysis catheter.As received, sample confirmed to have fracture/hole in the extension leg tubing at the junction with the luer hub.The customer's reported 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.A dhr review was not conducted since there was no reported lot number.A dhr review of the ship history report (shr) lots could also not be conducted since the distribution of the packaged good item number is also unknown, i.E.Previously distributed by angiodynamics or currently distributed by merit (new owner and manufacturer of the bioflo dialysis catheter product family).Labeling review: the following is provided as a reference from dfu item number 16600701-01: 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.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: BIOFLO DURAMAX
• 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: 21168366
• Report Number: 1317056-2025-00008
• Device Sequence Number: 17227414
• Product Code: MSD
• UDI-Device Identifier: H965103028030
• UDI-Public: H965103028030
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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 Model Number: 02-803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2025
• Supplement Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 05/08/2025
• 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