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	Particulates (1451); Inadequate Filtration Process (2308)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 submitted by the pharmaceutical customer that is relevant to the manufacturer's device has been identified.The report indicated that while using the mix2vial device to reconstitute a lyophilised drug product, particulate matter was observed floating within the syringe.The pharmaceutical customer reported that the sample was not returned for analysis and after review of the photos provided, the reported defect could not be verified.

• 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: 24314481
• Report Number: 3000223297-2026-00003
• Device Sequence Number: 4875671
• 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