BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLANT DUAL INJECTION SYSTEM

    MDR report key: 2843533 · Received September 13, 2012

    Report

    Report Number
    2843533
    Event Type
    Malfunction
    Date Received
    September 13, 2012
    Date of Event
    August 27, 2012
    Report Date
    September 13, 2012
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PER RADIOLOGY SUPERVISOR: WHEN TUBING IS REMOVED FROM SYRINGE, SOLUTION DRIPS ONTO HAND SWITCH CONNECTOR CAUSING A COMMUNICATION INTERRUPTION BETWEEN THE INJECTOR AND THE CONSOLE. THREE MONTHS PRIOR TO THIS EVENT IT HAPPENED AND A FIELD SERVICE ENGINEER CAME OUT TO INSPECT UNIT. HE SUGGESTED PUTTING A VELCRO ROLL AROUND THE CONNECTOR TO SOAK UP THE SOLUTION DRIP. LAST MONTH, THE SAME SITUATION, STAFF IS REQUESTING A MORE PERMANENT SOLUTION. A PATIENT WAS NOT ON THE TABLE AT TIME, STAFF NOTICED CONSOLE WAS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLANT DUAL INJECTION SYSTEM INJECTOR AND SYRINGE, ANGIOGRAPHIC, DUAL INJECTION SYSTEM DXT MEDRAD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES