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

Catalog Number	H965907031221
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	11/15/2018
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
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
• Common Device Name: STOPCOCK / ARTERIAL EXTENSION SET
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8141221
• Report Number: 1317056-2018-00225
• Device Sequence Number: 16580741
• Product Code: DQO
• UDI-Device Identifier: H965907031221
• UDI-Public: H965907031221
• 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): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1