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 Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
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
During a routine review of the maude database, an mdr that is relevant to the manufacturer's device has been identified.It was reported by a nurse that during drug preparation, water for injection could not be transferred into the drug vial.The issue of "no diluent transfer" was analyzed by the pharmaceutical customer's lab.During sample examination of the complaint in the lab, particles were observed on the diluent spike.

• 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: 24314500
• Report Number: 3000223297-2026-00002
• Device Sequence Number: 4942316
• Product Code: LHI
• UDI-Device Identifier: 07290108240429
• UDI-Public: (01)07290108240429(17)280601(10)H799
• 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): 05/19/2026

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: Health Professional
• Device Catalogue Number: 8074022
• Device Lot Number: H799
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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