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

Catalog Number	10302803
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported an end user experienced an issue when using a dialysis catheter from a bioflo duramax 15.5f 24cm dual valve sheath basic kit.On initiation of dialysis, the nurse noticed an air bubble coming in to the syringe while aspirating blood from arterial lumen of cvc.Upon closer inspection, a small amount of blood was leaking from the side of clear rubber part of arterial lumen of cvc.The catheter was removed and replaced due to this issue.
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).
Additional Manufacturer Narrative
Returned for evaluation was one (1) bioflo dialysis catheter.As received, the 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; 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.This is supported by the fact that the dialysis catheter device was in situ for more than 58 months.A manufacturing related root cause is unlikely since the device was in situ for more than 58 months.Dhr review of the packaging/assembly shr lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.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 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: 18400671
• Report Number: 1317056-2023-00188
• Device Sequence Number: 2759827
• Product Code: MSD
• UDI-Device Identifier: H965103028031
• UDI-Public: H965103028031
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K131260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• 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): 01/31/2024

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: 10302803
• Device Lot Number: UNKNOWN
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 01/27/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 01/31/2024
• 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 Age: 73 YR
• Patient Sex: Female