MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CONVENIENCE KIT

Catalog Number	H9656013086111
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A used device from the reported event has been returned to angiodynamics, however the evaluation is on-going.Upon completion of the investigation a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported, while using a convenience kit during an angiographic procedure, an air leak was noted.No air was injected and there was no patient injury.A device sample has been returned to angiodyanmics for evaluation.
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 (b)(4) 2016 angiodynamics complaint report was reviewed for the convenience kit product family for the failure mode "air bubbles noted." no adverse trend was identified.Returned for evaluation was one manifold with a syringe attached.No manufacturing non-conformances were visible on the devices.The connection sites between the male-to-ra adaptor and the manifold female side port appeared to be firmly attached, but not over-tightened.Under magnification, no cracked fittings or other damage was observed.The returned syringe was dry connected and disconnected to the proximal (end) female of the manifold three times.The syringe connected to the manifold without difficulty and remained firmly attached.The same functional check was performed on the syringe using a wet connection between the syringe and manifold.Again, the syringe remained firmly attached.Leak testing was then performed on the components and no leakage occurred.The syringe and manifold were primed with water, the manifold was capped off, and pressure was applied by hand.No leaks were noted at the connection sites.The individual components were leak tested per angiodynamics procedures, and passed.All fittings on the syringe and manifold were measured and found to be within specification.The reported complaint description cannot be confirmed.The samples were evaluated and were found to be visually, dimensional and functionally acceptable; the complaint does not appear to be a manufacturing related issue.Possible root cause may be inadequately secured connections between the syringe and the manifold, or the connections were not "finger tightened" prior to use as it is stated in the directions for use provided in the reported kit.(b)(4).

• Brand Name: ANGIODYNAMICS
• Common Device Name: CONVENIENCE KIT
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5864487
• Report Number: 1317056-2016-00117
• Device Sequence Number: 695985
• Product Code: OEZ
• UDI-Device Identifier: H9656013086111
• UDI-Public: H9656013086111
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2016

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: 04/30/2018
• Device Catalogue Number: H9656013086111
• Device Lot Number: 5024512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2016
• Supplement Report FDA Received Date: 09/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1