BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIX2VIAL¿ 20/20MM W-20UM FILTER

    MDR report key: 25048961 · Received April 30, 2026

    Report

    Report Number
    3000223297-2026-00014
    Event Type
    Malfunction
    Date Received
    April 30, 2026
    Report Date
    April 30, 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

    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 WHILE USING THE MIX2VIAL DEVICE TO RECONSTITUTE A LYOPHILISED DRUG PRODUCT, PARTICULATE MATTER WAS OBSERVED IN THE PRODUCT FOLLOWING RECONSTITUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190123 MIX2VIAL¿ 20/20MM W-20UM FILTER Set, i.V. Fluid transfer LHI WEST PHARMA. SERVICES IL, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1