MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD. VIAL ADAPTER 13MM SWABABLE

Catalog Number	8070101
Medical Device Problem Codes	Contamination (1120); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer, (b)(6), contacted the device manufacturer on (b)(6) 2025 to report during packaging of the swabable vial adapter (sva) with the customer's drug product, foreign particles were detected within the primary packaging of the devices and also within the sealing area of the primary packaging.Foreign particles were detected in multiple devices from lot k716 of the swabable vial adapters (sva).The customer confirmed that the affected devices are segregated, not for use.As 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
This complaint is currently under investigation.Upon completion of the investigation, a follow-up report will be submitted.

• Brand Name: VIAL ADAPTER 13MM SWABABLE
• Common Device Name: VIAL ADAPTER 13MM SWABABLE
• 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: 23778662
• Report Number: 3000223297-2025-00008
• Device Sequence Number: 10083959
• Product Code: LHI
• UDI-Device Identifier: 07290108240498
• UDI-Public: (01)07290108240498(17)271231(10)K716
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K072511
• 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): 06/04/2026

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: 8070101
• Device Lot Number: K716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2025
• 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