BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIX2VIAL TRANSFER DEVICE

    MDR report key: 23250979 · Received October 8, 2025

    Report

    Report Number
    2032282-2025-00021
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Report Date
    October 9, 2025
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD.
    Product Code
    LHI
    PMA / PMN Number
    K231071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE AND PHOTOS WERE PROVIDED. THE COMPLAINT IS NOT CONFIRMED AS NO MANUFACTURING ISSUES WITH THE PROCESS, EQUIPMENT, OR MATERIAL WERE IDENTIFIED THAT COULD HAVE ADVERSELY IMPACTED THE QUALITY OF THE PRODUCT. THERE WAS NO TRENDS IDENTIFIED, NO REPORTED PATIENT INJURY,AND NO REPORTED MISSED DOSE.NO ROOT CAUSE RELATED TO MANUFACTURING WAS IDENTIFIED IN THE COURSE OF THE INVESTIGATION. AS A RESULT, ESCALATION, DEVIATION, AND CAPA ARE NOT WARRANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED, "THE UNRELIABLE MIXING DEVICE CAUSED TO TAKE TWICE THE TIME OR MORE TO ADMINISTER VONVENDI ADMINISTRATION DURATION TOO LONG." WHEN PATIENT TRIED TO COMPLETE THE TRANSFER BY WARMING THE WATER BOTTLE WITH HAND, THE WATER LEAKED OUT THROUGH THE MIXING DEVICE. PATIENT DID BEST TO KEEP THE VIALS IN ALIGNMENT, BUT THAT WAS DIFFICULT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2583502 MIX2VIAL TRANSFER DEVICE Set, i.V. Fluid transfer LHI WEST PHARMA. SERVICES IL, LTD. H799

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male