MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; STOPCOCK / ARTERIAL EXTENSION SET

Catalog Number	H965907030621
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A photo has been received from the distributor which confirms the reported event.The investigation is on-going and upon completion , a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(4), blue non-vented port protector cap connected to stopcock end port fitting should have been a vented white port protector cap.The non-vented cap possibly compromises a sterile pathway for this device during the sterilization process.This one unit was found during 100% incoming inspection at the distributor and had not been distributed to a hospital.
Additional Manufacturer Narrative
A review of the device history records was performed for the reported packaging lot 5319428 for any deviations related to the reported defect of the complaint.The review confirms that the lot met all material, assembly and performance specifications.A review of the recent angiodynamics complaint report was performed for the stopcock/manifold product family and the failure mode " cap incorrectly constructed/assembled." no adverse trend was indicated.The sample was not returned to angiodynamics, however a photo was provided which confirmed the reported issue: the incorrect port protector was attached to the end port of the stopcock.The shipment of devices from lot 5319428 shipped to the reported distributor consisted on (b)(4) units.(b)(4).The root cause of the incorrect cap attachment has been determined to be a manufacturing assembly error in which responsible employees failed to properly attach the components and verify the proper attachments per the drawing and packaging op.Codes.Packages are 100% visualized for this type of non-conformance and the employees who packaged the affected lot did not identify the non-conforming unit during their inspection.In an effort to heighten awareness of the performance of our products in the field, recent complaints are reviewed in a weekly meeting with the entire department.All responsible packaging employees have been retrained on the applicable procedures.(b)(4).

• Brand Name: ANGIODYNAMICS
• Common Device Name: STOPCOCK / ARTERIAL EXTENSION SET
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7804936
• Report Number: 1317056-2018-00162
• Device Sequence Number: 13820298
• Product Code: DQO
• UDI-Device Identifier: H965907030621
• UDI-Public: H965907030621
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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: Other
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: H965907030621
• Device Lot Number: 5319428
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1