BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD INJECTION SYSTEM

    MDR report key: 3212882 · Received July 2, 2013

    Report

    Report Number
    MW5030799
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 2, 2013
    Manufacturer
    MEDRAD - BAER
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE SECOND INJECTION OF THE RIGHT CORONARY ARTERY WITH THE MEDRAD INJECTION SYSTEM STAFF NOTICED AIR BUBBLES IN THE ARTERY. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300573 MEDRAD INJECTION SYSTEM SINGLE PATIENT DISPOSABLE SET DXT MEDRAD - BAER 131403

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other