BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIX2VIAL¿ 20/20MM W-20UM FILTER

    MDR report key: 24999065 · Received April 27, 2026

    Report

    Report Number
    3000223297-2026-00010
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Report Date
    April 27, 2026
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD.
    Product Code
    LHI
    PMA / PMN Number
    K031861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ORIGINAL EVENT IS REFERENCED AS HAVING TAKEN PLACE IN GM ACCORDING TO THE INFORMATION PROVIDED IN THE MAUDE DATABASE. HOWEVER, GIVEN THAT WEST HAS BEEN MADE AWARE OF THE EVENT VIA THE REPORT THAT OUR PHARMACEUTICAL CUSTOMER MADE TO THE FDA, THE ORIGINAL REPORTER DETAILS ARE NOT KNOWN TO WEST. THEREFORE, THE REPORTER DETAILS THAT HAVE BEEN REFERENCED IN SECTION E1 ARE THOSE OF WEST'S PHARMACEUTICAL CUSTOMER. THE COMPLAINT IS CURRENTLY UNDER INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DURING A ROUTINE REVIEW OF THE MAUDE DATABASE, A REPORT WAS IDENTIFIED WHICH HAD BEEN MADE TO THE FDA BY THE PHARMACEUTICAL CUSTOMER, ABOUT WHICH THE DEVICE MANUFACTURER WAS PREVIOUSLY UNAWARE. THE REPORT INDICATED THAT PARTICLES WERE OBSERVED BY THE MANUFACTURER'S PHARMACEUTICAL CUSTOMER ON A RETURNED SAMPLE (DUE TO NO DILUENT TRANSFER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159881 MIX2VIAL¿ 20/20MM W-20UM FILTER Set, i.V. Fluid transfer LHI WEST PHARMA. SERVICES IL, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1