BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENIE CLOSED VIAL ACCESS DEVICE

    MDR report key: 2140471 · Received June 23, 2011

    Report

    Report Number
    2140471
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    June 17, 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 - TRIED TO USE A GENIE #20132-01 FOR OXALIPLATIN (HAZARDOUS DRUG), BUT PRODUCT FAILED TO INFLATE AND COULD NOT DRAW UP DOSE. I HAD TO PHYSICALLY REMOVE THE GENIE PRODUCT; RESPIKED WITH A UNIVERSAL SPIKE #20133-01. THE CLOSE-SYSTEM BENEFIT WAS LOST, AND CHEMOTHERAPY CONTAMINATED THE BARRIER ISOLATOR AND GLOVES.

    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 *