BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLANT

    MDR report key: 2475363 · Received February 29, 2012

    Report

    Report Number
    2475363
    Event Type
    Malfunction
    Date Received
    February 29, 2012
    Date of Event
    February 28, 2012
    Report Date
    February 29, 2012
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MALFUNCTION OF IV TUBING THAT CONNECTS TO CT SYRINGE INJECTOR. IT WAS A DISCONNECTION OF THE TUBING (THE T-PIECE) AS IF IT WAS NOT GLUED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLANT SYRINGE, CONTRAST INJECTION DXT MEDRAD, INC. * 119534

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES