BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLANT

    MDR report key: 2413282 · Received January 11, 2012

    Report

    Report Number
    2413282
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    January 6, 2012
    Report Date
    January 11, 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

    UPON OPENING MEDRAD SYRINGE PACKAGING, THE TUBING DISCONNECTED AT THE T-CONNECTOR SITE. CT TECH STATED IT LOOKED AS IF THE CONNECTIONS SITE CAME UNGLUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLANT SYRINGE, CONTRAST INJECTION DXT MEDRAD, INC. * 116518

    Patients

    Seq Age Sex Outcome Treatment
    1 *