BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENIE CLOSED VIAL ACCESS DEVICE

    MDR report key: 2140448 · Received June 23, 2011

    Report

    Report Number
    2140448
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    ICU MEDICAL
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PER STAFF MEMBER - WHEN I WENT TO RECONSTITUTE HERCEPTIN, THE GENIE WOULD NOT ALLOW ME TO PUSH DILUENT INTO THE VIAL. I WAS RECONSTITUTING THREE VIALS. THE FIRST VIAL WORKED FINE WITH THE GENIE. THE SECOND AND THIRD VIALS WOULDN'T ALLOW ME TO PUSH DILUENT INTO THE VIALS. IT HAS ALWAYS ALLOWED US IN THE PAST. SINCE I COULDN'T PUSH DILUENT THROUGH TO RECONSTITUTE THE VIAL, I HAD TO PULL OUT THE GENIE AND RESPIKE THE VIALS WITH THE UNIVERSAL CLIP-ON VENTED VIAL ADAPTER(#20133-01). ONCE I RESPIKED THE VIALS WITH THESE ADAPTERS, I WAS ABLE TO RECONSTITUTE THE VIALS EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENIE CLOSED VIAL ACCESS DEVICE GENIE CLOSED VIAL ACCESS DEVICE FMF ICU MEDICAL * 20132-01

    Patients

    Seq Age Sex Outcome Treatment
    1 *