MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD. MIX2VIAL¿ 20/20MM W-20UM FILTER; SET, I.V. FLUID TRANSFER

Catalog Number	8074022
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint is currently under investigation.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
The customer, takeda pharmaceuticals, contacted the device manufacturer on 28th january 2026 to report that during incoming inspection, one device was identified with a partially opened seal near a crease on the blister pack seal contact area.This presents a potential breach to the 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.

• Brand Name: MIX2VIAL¿ 20/20MM W-20UM FILTER
• Common Device Name: SET, I.V. FLUID TRANSFER
• 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: 24444260
• Report Number: 3000223297-2026-00004
• Device Sequence Number: 10443162
• Product Code: LHI
• UDI-Device Identifier: 07290108240429
• UDI-Public: (01)07290108240429(17)301031(10)L416
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K031861
• 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): 07/15/2026

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: 8074022
• Device Lot Number: L416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 07/15/2026
• Was Device Evaluated by Manufacturer? (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