MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; ARTERIAL EXTENSION SET

Catalog Number H965907030501

Device Problem Component Misassembled (4004)

Patient Problem Not Applicable (3189)

Event Date 08/08/2019

Event Type  malfunction  

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 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.

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
• Type of Device: ARTERIAL EXTENSION SET
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8964613
• MDR Text Key: 156772843
• Report Number: 1317056-2019-00117
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: H965907030501
• UDI-Public: H965907030501
• Combination Product (y/n): N
• PMA/PMN Number: K790082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1