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

Catalog Number	8072003
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The device manufacturer's pharmaceutical customer, apg europe, contacted the device manufacturer to report packaging damage.On 16dec2024, apg europe provided additional details and photos showing that packaging damage resulted in breach of sterility of the device.This deficiency was found prior to use.The device had not yet entered into the distribution stage to the end user (i.E.Being put into service), there was no health impact to the end user.
Additional Manufacturer Narrative
According to the manufacturer's records, lot# k243 was manufactured according to relevant procedures, tested before release, packed, according to specifications and there were no non-conformances found.The manufacturer's batch records were reviewed no ncm's were found.According to the sterilization sub-contractor review, no issues were noticed for lot# k243 during or after the sterilization process.The proof of delivery received from the shipping vendor was signed with a remark noting damage to one (1) pallet.This indicates that the shipment was received with damage and is under the manufacturer's responsibility.The photos provided by the customer show damage was caused to the thermal cover, secondary and primary packaging affecting the carton boxes and blisters.Most likely, the damage is related to a forklift operation.Therefore, the most probable root cause of this issue is human error, resulting from failure to follow procedure which led to damage while improperly using the forklift.

• 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: 21141205
• Report Number: 3000223297-2025-00001
• Device Sequence Number: 13077177
• Product Code: LHI
• UDI-Device Identifier: 07290108240177
• UDI-Public: (01)07290108240177(17)291031(10)K243
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K963583
• 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): 06/17/2025

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: 8072003
• Device Lot Number: K243
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2024
• 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