MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD. VIAL ADAPTER

Catalog Number	8072050
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation of this issue is ongoing.Upon completion of the investigation and if additional information is provided from the manufacturer's customer a follow-up report will be submitted.
Event or Problem Description
The customer, baxter healthcare corporation, contacted the device manufacturer on 16jan2025 to report that upon incoming inspection at the customer site.Lot k513 was inspected and it was noticed that some of the vial adapter devices were deformed and stuck together.
Additional Manufacturer Narrative
No samples were returned by the customer.However, according to the obtained pictures, the products were detected with deformed and open blisters and the reported issue was verified.According to the manufacturer's records, lot# k513 was manufactured according to relevant procedures, tested before release and packed according to specifications.The manufacturer's batch records were reviewed, no non-conformances were found.All quality control inspections including visual inspections were conducted according to the procedures, no deviation were noticed.Retained samples from lot# k513 were visually inspected by the contract manufacturer during production, no findings were observed.According to the contract manufacturer's sterilization documents review, no deviations were noticed for lot# k513.According to available data, it is most probable that lot# k513 was not exposed to high temperatures during the manufacturing and sterilization process.Hence, this deviation likely occurred during shipment of lot# k513 which is the responsibility of the manufacturer until the shipment arrives at the customer.Therefore, the root cause of this event is due to insufficient temperature monitoring over the entire door to door shipment process.A corrective and preventative action was initiated by the manufacturer to define appropriate storage and shipping conditions for final goods throughout the entire supply chain.

• Brand Name: VIAL ADAPTER
• Common Device Name: VIAL ADAPTER
• Manufacturer (Section D): WEST PHARMA. SERVICES IL, LTD.; 4 hasheizaf street; ra'anana, 43664 11; IS 4366411
• Manufacturer (Section G): WEST PHARMA. SERVICES IL, LTD.; 4 hasheizaf street; ra'anana, 43664 11; IS 4366411
• Manufacturer Contact: lynn lundy ; 530 herman o. west drive; exton, PA 19341 ; 4848853298
• MDR Report Key: 21367727
• Report Number: 3000223297-2025-00003
• Device Sequence Number: 8564539
• Product Code: LHI
• UDI-Device Identifier: 07290108241075
• UDI-Public: (01)07290108241075(17)290531(10)K513
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K001293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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 Catalogue Number: 8072050
• Device Lot Number: K513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 06/15/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown