MAUDE Adverse Event Report: West Pharma. Services IL, Ltd. Swabable Vial Adapter 13mm; Set, I.V. Fluid Transfer

Catalog Number	8070101
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer, dompe farmaceutici spa, contacted the device manufacturer on 25aug26 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.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
Note: with regard to section h10, report 3000223297-2025-00009, 3000223297-2026-00021, 3000223297-2026-00024 and 3000223297-2026-00025 are also related to this event.Due to space restrictions in h10, these relevant reports are noted here in h11.The reported issued is currently under investigation.Upon completion of the investigation, a follow-up report will be submitted.

• Brand Name: Swabable Vial Adapter 13mm
• Common Device Name: Set, I.V. Fluid Transfer
• Manufacturer (Section D): West Pharma. Services IL, Ltd.; 4 hasheizaf street; ra'anana, 43664 1; IS 436641
• 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 ; +1(484)885-3298
• MDR Report Key: 50882976
• Report Number: 3000223297-2026-00043
• Device Sequence Number: 18598678
• Product Code: LHI
• UDI-Device Identifier: 07290108240498
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: M086
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/24/2026
• 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