BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SYRINGE KIT

    MDR report key: 1314038 · Received February 13, 2009

    Report

    Report Number
    MW5009967
    Event Type
    Malfunction
    Date Received
    February 13, 2009
    Date of Event
    February 2, 2009
    Report Date
    February 3, 2009
    Manufacturer
    MEDRAD, INC.
    Product Code
    IZQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT IMAGING FOR A CT CHEST WITH CONTRAST. INJECTION SYRINGES AND TUBING WERE SET UP AND PRIMED. PT UNDERWENT EXAM AND LEFT. ON REVIEW OF CT IMAGES, RADIOLOGIST NOTED AIR IN CARDIAC AREA AND IMMEDIATELY RECALLED PT FOR MONITORING AND RESCANNING. RADIOLOGIST ESTIMATED 4CC. PT RETURNED FOR EVAL WITH PCP, WAS ASYMPTOMATIC AND THEN RETURNED TO RADIOLOGY FOR A F/U CARDIAC SCAN, ALSO NEGATIVE. AIR INJECTED DURING CT CHEST IMAGING. DUAL HEAD INJECTOR WAS USED IN CONJUNCTION WITH STELLANT STERILE DISPOSABLE SYRINGE SET AND T-PORT EXTENSION SET. DOSE OR AMOUNT #1, #2: 1, FREQUENCY #1, #2: ONCE, ROUTE #1, #2: VIA IV. DATES OF USE: #1 & #2. 2009. DIAGNOSIS OR REASON FOR USE: #1 & #2. CONTRAST USE - INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SYRINGE KIT STELLANT DUAL HEAD INJECTOR IZQ MEDRAD, INC. 75708
    2 T PORT TENSION SET STELLANT DUAL HEAD INJECTOR IZQ MEDRAD, INC. 0060985469
    3 MEDRAD DUAL HEAD INJECTOR STELLANT DUAL HEAD INJECTOR IZQ MEDRAD, INC. STELLANT DUAL HEAD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR