MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CONVENIENCE KIT

Catalog Number	H965600334131
Medical Device Problem Code	Air Leak (1008)
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
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 angiodynamics january 2016 complaint report was reviewed for the convenience kit product family and the failure mode, "air bubbles noted." no adverse trend was identified.Visual inspection of the returned pressure monitoring line/disposable transducer assembly noted a void in the bond between the two components.No other visual defects were apparent.When leak tested in water, bubbles were observed escaping from the bond location.The device also failed pressure testing with air.The root cause has been determined to be insufficient bonding adhesive which would be the result of the responsible employees failing to follow proper procedures.All employees involved in the assembly of the reported device lot have been made aware of this event and have been re-trained on the applicable procedures.Process controls in place include visual inspection for proper bonds and leak testing performed on an aql basis.(b)(4).
Event or Problem Description
As reported, when convenience kit was being utilized in the cath lab, it was noted that air was being introduced into the system and "back flowing into the transducer line." no patient injury was reported.The used device has been returned to angiodyanamics for evaluation.

• Brand Name: ANGIODYNAMICS
• Common Device Name: CONVENIENCE KIT
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5720181
• Report Number: 1317056-2016-00032
• Device Sequence Number: 10837623
• Product Code: OEZ
• UDI-Device Identifier: H965600334131
• UDI-Public: H965600334131
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/10/2016

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: 05/31/2018
• Device Catalogue Number: H965600334131
• Device Lot Number: 4894897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2016
• Initial Report FDA Received Date: 06/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1