MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CONVENIENCE KIT

Catalog Number	H749601500351
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2019
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 may 2019 angiodynamics complaint report was reviewed for the y-adaptors and convenience kit product families for the failure mode "air bubbles noted." no adverse trend was identified.Four (loose) y-adaptors were returned for evaluation.A visual inspection was performed on all four of the returned samples.No visible defects were noted.The caps on all four of the returned samples were in the opened position as received.The samples were air leak tested at 20psi of pressure using a heise.All four of the returned samples passed the leak test requirements per angiodynamics' procedures.The caps were able to be tightened and then loosened without difficulty during the leak test.The reported complaint description cannot be confirmed nor can a root cause for the event be determined.The samples were tested and met the visual and functional acceptance criteria as per angiodynamics procedures.((b)(4)).
Event or Problem Description
As reported, end user is complaining about the touhy-borst valve on the y-adaptor in their convenience kit letting air into the system.No air has been injected and there has been no patient injury.A used device will be returned to angiodynamics 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: 8709444
• Report Number: 1317056-2019-00077
• Device Sequence Number: 14020342
• Product Code: OEZ
• UDI-Device Identifier: H749601500351
• UDI-Public: H749601500351
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

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: 03/31/2022
• Device Catalogue Number: H749601500351
• Device Lot Number: 5455140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1