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

Catalog Number	H965103028031
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Returned for evaluation was a bioflo dialysis catheter.As received, it was noted during the visual inspection that there was a hole just below the female luer {red clamp side}.The reported complaint device failure mode of hole noted in extension tubing near hub junction was confirmed.Hole was observed in the arterial extension tube adjacent to the flat section of the hub, i.E.90° from the parting line the customer's complaint description is confirmed.There is a small crack/holein the extension tube adjacent to the hub.There are no visible indications that the failure is related to either the manufacturing process or associated tooling.A ship history record review of the packaging and dialysis catheter assembly lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.A potential root cause for this failure is over torqueing of the hub to extension tubing junction during cleaning/use 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 dfu item number 16600701-01: 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.Repeated over tightening of bloodlines, syringes, and caps will reduce connector life and could lead to potential connector failure.· 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.Note: endexo technology is intended to reduce catheter-related thrombus, and is not intended to treat or eliminate existing thrombus 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.(b)(4).
Event or Problem Description
As reported: the event occurred in the dialysis room, when the nurse connected the catheter to the dialysis machine, was a leak between the junction the white piece (where is the luer lock (hub?) i don´t know if is the arterial or venous arm) with the transparent tube.[extension leg, detached/separated/fractured] it was reported the catheter was removed and replaced.There was no harm or injury to the patient due to this event.The reported defective disposable device has been returned to the manufacturer for evaluation.

• Brand Name: BIOFLO DIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny
• MDR Report Key: 9805812
• Report Number: 1317056-2020-00053
• Device Sequence Number: 10956935
• Product Code: MSD
• UDI-Device Identifier: H965103028031
• UDI-Public: H965103028031
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K131260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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: H965103028031
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1