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

Catalog Number	H965103038080
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2019
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 "extension leg - detached/separated/fractured".No adverse trend was indicated.It was noted during the visual inspection of the returned catheter that there was a hole just below the female luer {red clamp side}.The reported complaint device failure mode of "leakage" was confirmed.A hole was observed in the arterial extension tube adjacent to the flat section of the hub, i.E.90° from the parting line.Although the damage to the catheter was confirmed, there are no visible indications that the failure is related to either the manufacturing process or associated tooling.The exact root cause is unknown, however, a potential root cause for this failure is the end user over-torquing the hub-to-extension tubing junction during cleaning/use of the device.((b)(4)).
Event or Problem Description
Notification of an event which occurred at a (b)(6) hospital participating in an angiodynamics clinical study on bioflo dialysis catheters: "device was observed to leak from hub.Had been in situ for 8 months.Malfunction did not result in ae/sae.Line was exchanged".The used catheter was returned to angiodynamics for evaluation.

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8511118
• Report Number: 1317056-2019-00054
• Device Sequence Number: 16624660
• Product Code: MSD
• UDI-Device Identifier: H965103038080
• UDI-Public: H965103038080
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2019

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: 04/30/2019
• Device Catalogue Number: H965103038080
• Device Lot Number: 5065559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1