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

Catalog Number	10302804
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2022
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.
Event or Problem Description
During a dialysis treatment, blood was noted to be leaking from the aterial lumen of the bioflo chronic dialysis catheter 15.5f 28cm.Initially, this was reported as a small blood leak; however, it later became heavy and prevented the patient's dialysis treatment from being completed.Patches were used to compress and minimize the blood loss until catheter was removed and replaced.The patient did not experience any adverse effects or harm as a result of this incident.
Additional Manufacturer Narrative
Returned for evaluation was one bioflo duramax catheter.As received, no visual defects were noted.No holes were noted during the visual inspection to the extension tubing {blue clamp side} or {red clamp side}.Each catheter lumen was pressurized with air at 76 psi and submerged in water to check for leaks.No leaks were detected in either lumen.The customer's complaint description of catheter leak could not be confirmed.No manufacturing non-conformances or abnormalities were noted, and no leaks were detected during sample review.The customer experience with this device cannot be definitively determined, however, unsecure connection to luer hub is potential root cause.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: 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 adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).
Event or Problem Description
Additional information obtained reported: the device was accessed 3 times weekly and only tightened by hand.No sharp objects were used for dressing , and chlorhexidine solution of 2% was used for cleaning the device and allowed to fully dry before connecting the dialysis device.

• Brand Name: BIOFLO DIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 14453278
• Report Number: 1317056-2022-00078
• Device Sequence Number: 14582507
• Product Code: MSD
• UDI-Device Identifier: H965103028041
• UDI-Public: H965103028041
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K131260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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 Expiration Date: 07/31/2022
• Device Catalogue Number: 10302804
• Device Lot Number: 5566241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2020
• 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: 49 YR
• Patient Sex: Female
• Patient Weight: 58 KG