MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; ARTERIAL EXTENSION SET

Catalog Number	H965907030501
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device from the reported event has been returned to angiodynamics.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)(6), 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
The device history records for the reported packaging lot were reviewed for any deviations related to the reported defect of the complaint.The review confirms that the lot met all material, assembly and performance specifications.The july 2019 angiodynamics complaint report was reviewed for the stopcock/manifold product family and the failure mode "cap incorrectly/constructed/assembled." no adverse trends were indicated.Based on the returned sample and attached pictures supplied from the customer, the customer's complaint of "1 package had port protectors attached incorrectly on stopcock " is deemed confirmed.The root cause for the incorrectly assembled cap is that responsible employees failed to properly attach the components and verify the proper attachments per the specification drawing and packaging procedures.Packages are 100% visualized for this type of non-conformance per manufacturing procedures, and recent updates have been performed to provide awareness and guidance regarding the orientation of device handles and placement of vented/non-vented caps in regards to sterile gas pathways through the device.The employees who packaged the affected lot did not identify the non-conforming unit during their inspections.These employees have been re-trained on the appropriate procedures.Additional corrective action is on-going to replace non-vented caps with vented caps on this and similar device styles.((b)(4)).

• Brand Name: ANGIODYNAMICS
• Common Device Name: ARTERIAL EXTENSION SET
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8964613
• Report Number: 1317056-2019-00117
• Device Sequence Number: 13991064
• Product Code: DQO
• UDI-Device Identifier: H965907030501
• UDI-Public: H965907030501
• 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): 09/30/2019

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: 05/31/2022
• Device Catalogue Number: H965907030501
• Device Lot Number: 5479539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Supplement Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1