MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; CATHETER, HEMODIALYSIS

Catalog Number	H965103038041
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated 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.The recent angiodynamics complaint report was reviewed for the bioflo dialysis product family and the failure mode "cracked hub." no adverse trend was identified.The reported complaint description cannot be confirmed nor can a definitive root cause be established, as no sample was returned.A possible root cause for the cracked hub may be due to an over tightened connection with a mating male luer.This is the only reported complaint for this failure mode in the past 15 months for the bioflo dialysis product family.The directions for use (established) packaged with the dialysis catheter contains the following statements : "· examine catheter lumen and extensions before and after each treatment for damage.Use only luer lock (threaded) connectors with this catheter.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.".((b)(4)).
Event or Problem Description
Angiodynamics was made aware of this event which occurred during an adopt study of the bioflo dialysis catheter in (b)(6): an indwelling bioflo dialysis catheter was removed and replaced due to a cracked hub.The device was discarded and a new dialysis catheter was placed on the same day.There were no patient complications or patient injury.

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: CATHETER, HEMODIALYSIS
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8257736
• Report Number: 1317056-2019-00010
• Device Sequence Number: 2306908
• Product Code: MSD
• UDI-Device Identifier: H965103038041
• UDI-Public: H965103038041
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2019

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: 09/30/2019
• Device Catalogue Number: H965103038041
• Device Lot Number: 5151194
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1