BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLANT

    MDR report key: 2992141 · Received February 28, 2013

    Report

    Report Number
    2992141
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 28, 2013
    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 DEVICE, IT WAS NOTED THAT THE END OF THE "CURLY" CONNECTION TUBING WAS NOT CONNECTED TO THE END CAP (PATIENT CONNECTION END) IN THE CT INJECTOR KIT. IT LOOKS AS IF PART OF THE SMALL TUBING IS STUCK IN THE END PIECE, BUT THE TUBING IS SUPPOSED TO BE CONNECTED AND WAS NOT.THE CT DEPARTMENT STATES THEY FOUND TWO PACKAGES IN TOTAL LIKE THIS RECENTLY AND HAVE SEEN THIS HAPPEN BEFORE ABOUT 2-3 TIMES. NO PATIENT WAS INVOLVED/HARMED. DEFECTIVE TUBING NOTED UPON PACKAGE OPENING.======================MANUFACTURER RESPONSE FOR MEDRAD STERILE DISPOSABLE SYRINGE WITH 60" T-CONNECTOR AND PRIME TUBE, STELLANT (PER SITE REPORTER).======================SPOKE WITH THE MANUFACTURER'S COMPLIANCE STAFF. THEY STATED THAT I SHOULD WAIT ABOUT 5 BUSINESS DAYS SO MEDRAD COULD REVIEW COMPLAINT TO SEE IF THEY WOULD LIKE TO RECEIVE THE PRODUCT FOR INVESTIGATION. THEY ARE PLANNING TO SEND REPLACEMENT BOX.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CT CONTRAST INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86878 STELLANT INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT MEDRAD, INC * 139599

    Patients

    Seq Age Sex Outcome Treatment
    1 *