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)
Date of Event	08/29/2016
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 (b)(6) 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 a used manifold assembly with a syringe, stopcock and pressure monitoring line (pml) no manufacturing non-conformances were visible on the devices.All connection sites appeared firmly attached, but not over-tightened.Under magnification, no cracked fittings or other damage was observed.Individual air leak testing was performed on the manifold, stopcock and pml.Vacuum air leak testing was performed on the syringe.All components passed the testing.Measurements were taken of all male and female threads and tapers and all were found to be within dimensional specification.The reported complaint description for air entering the manifold system cannot be confirmed.The returned, used 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).
Event or Problem Description
As reported, while utilizing a convenience kit, " air was leaking into the manfold system." no air was injected and there was no patient injury.The used sample has been 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: 5976612
• Report Number: 1317056-2016-00141
• Device Sequence Number: 697455
• 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
• Report Date (Section B): 08/29/2016

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: 07/31/2018
• Device Catalogue Number: H9656013086111
• Device Lot Number: 5062515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2016
• Initial 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