BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTLOAD

    MDR report key: 5079928 · Received September 16, 2015

    Report

    Report Number
    5079928
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    August 18, 2015
    Report Date
    September 9, 2015
    Manufacturer
    BRACCO DIAGNOSTICS INC.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT. WAS GETTING A CT WITH CONTRAST WHEN THE PLASTIC POWER INJECTOR EXPLODED IN THE CT. NO INJURIES FROM EVENT, BUT FAMILY AND STAFF WERE COVERED IN CONTRAST. A SECOND CT TECH ATTEMPTED TO REDO THE TEST AND HAD A SIMILAR, BUT LESSER EXPLOSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613093 FASTLOAD INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT BRACCO DIAGNOSTICS INC. 017347

    Patients

    Seq Age Sex Outcome Treatment
    1