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

Catalog Number H965907031221

Device Problem Component Misassembled (4004)

Patient Problem Not Applicable (3189)

Event Date 11/15/2018

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

A review of the device history records was performed for the reported packaging lot 5377269 for item number h965907031221 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 recent angiodynamics complaint report was reviewed for the stopcocks product family and the failure mode "cap incorrectly/constructed/assembled." no adverse trend was identified.Based on the picture/sample supplied by the complaint reporter the complaint is deemed confirmed for an additional port protector attached to the side port of the stopcock.The most probable root cause for the product assembled incorrectly is that responsible employees failed to properly attach the components and verify the proper attachments per the drawing and packaging procedures.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 inspections.As corrective action, a department-wide re-training was performed emphasizing the importance of proper component assembly to create the required sterile pathways.Additionally, a revision is being performed to the component packaging procedure to highlight the importance of correct product assembly.(b)(4).

• Brand Name: ANGIODYNAMICS
• Type of Device: STOPCOCK / ARTERIAL EXTENSION SET
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8141221
• MDR Text Key: 130040694
• Report Number: 1317056-2018-00225
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: H965907031221
• UDI-Public: H965907031221
• 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: 02/28/2019

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
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: H965907031221
• Device Lot Number: 5377269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/07/2018
• Supplement Dates Manufacturer Received: 11/15/2018
• Supplement Dates FDA Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1