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

Catalog Number	H965103038031
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device from the reported event is expected to return, but has not yet been received.Upon receipt of the sample and completion of the investigation, a supplemental medwatch will be submitted.(b)(4).Device not yet returned to manufacturer.
Event or Problem Description
As reported by hospital in (b)(6), an indwelling dialysis catheter was removed and replaced due to a hole located "at the end of the extension tubing ender the end luer cap." the patient condition was reported as being "unaffected" by the event.
Additional Manufacturer Narrative
A recent angiodynamics complaint report was reviewed for the product family for the bioflo dialysis product family and the failure mode, "extension leg failure." no adverse trend was indicated.Returned was a used catheter which was confirmed to have a hole in the venous extension tube just under the luer on the front side, as well as a hole in the arterial extension tube just under the luer on the front and back sides.Measurements were taken of the i.Ds, and o.Ds of the venous and arterial extension tubes.Both were found to be within specification.There was no indication that the failure was related to either the manufacturing process or associated tooling.As a definitive root cause for this event could not be determined, a capa has been initiated to provide further investigation and determine if corrective action is required.Manufacturing process controls for the dialysis catheter include visual inspection for damage or defects, 100% leak testing, and guidewire insertion testing to verify lumen patency.(b)(4).

• Brand Name: ANGIODYNAMICS / BIOFLO / DURAMAX
• Common Device Name: CATHETER, HEMODYALISIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5605399
• Report Number: 1317056-2016-00059
• Device Sequence Number: 18978081
• Product Code: MSD
• UDI-Device Identifier: H965103038031
• UDI-Public: H965103038031
• 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: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup

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: H965103038031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2016
• Supplement Report FDA Received Date: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1