BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS LIFESCIENCES

    MDR report key: 401210 · Received June 19, 2002

    Report

    Report Number
    MW1025389
    Event Type
    Malfunction
    Date Received
    June 19, 2002
    Date of Event
    June 5, 2002
    Report Date
    June 19, 2002
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    MQT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SYRINGE IN CLOSED INJECTATE DELIVERY SYSTEM WILL NOT ASPIRATE. THIS HAPPENED WITH TWO IDENTICAL KITS WITH THE SAME LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS LIFESCIENCES CO SET + CLOSED INJECTATE DELIVERY SYSTEM MQT EDWARDS LIFESCIENCES 93610 58123593
    2 EDWARDS LIFESCIENCES CO SET + CLOSED INJECTATE DELIVERY SYSTEM CBT EDWARDS LIFESCIENCES 93610 58123593

    Patients

    Seq Age Sex Outcome Treatment
    1 *