MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; STOPCOCKS / MANIFOLDS

Catalog Number	H749800383011
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/21/2015
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 february 2016 angiodynamics complaint report was reviewed for the manifolds product family and the failure mode "air bubbles noted." no adverse trend was identified.The reported complaint description cannot be confirmed, as no sample was returned for evaluation.A potential root cause may be that the end user did not adequately secure connections between the manifold and the device to which they were connecting prior to use.Angiodynamics manufacturing process controls include an end of lot leak test based on an aql.(b)(4).Device discarded by end user.
Event or Problem Description
As reported by angiodynamics' distributor in (b)(6): end user hospital in (b)(6) reports "air leaking into 3-way manifold connection." device is sold to (b)(6), non-sterile for further processing.No customer complications or injury were reported.

• Brand Name: ANGIODYNAMICS
• Common Device Name: STOPCOCKS / MANIFOLDS
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5551884
• Report Number: 1317056-2016-00051
• Device Sequence Number: 13582627
• Product Code: FMG
• UDI-Device Identifier: H749800383011
• UDI-Public: H749800383011
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K782095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2016

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: 06/25/2018
• Device Catalogue Number: H749800383011
• Device Lot Number: 4906803
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2016
• Initial Report FDA Received Date: 04/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1