BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIEBEL-FLARSHEIM INJECTOR

    MDR report key: 820545 · Received February 20, 2007

    Report

    Report Number
    820545
    Event Type
    Injury
    Date Received
    February 20, 2007
    Date of Event
    February 6, 2007
    Report Date
    February 16, 2007
    Manufacturer
    MALLINCKRODT
    Product Code
    MJS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CT SCAN, IT WAS NOTICED THAT PATIENT HAD AIR IN THE HEART. IT WAS SEEN IN THE RT. AXILLARY AND SUBCLAVIAN VEIN AS WELL AS THE SUPERIOR VENA CAVA, RT. ATRIUM, RT. VENTRICLE AND MAIN PULMONARY TRUNK. PT. NEEDED TO BE INTUBATED AND PLACED ON VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIEBEL-FLARSHEIM INJECTOR CONTRAST MEDIA INJECTOR MJS MALLINCKRODT 800005 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening| R TYCO MALLINCKRODT OPTIRAY 300 #L446H