BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLANT DUAL SYRINGE KIT/QUICK FILL TUBE

    MDR report key: 1663593 · Received April 19, 2010

    Report

    Report Number
    1663593
    Event Type
    Malfunction
    Date Received
    April 19, 2010
    Date of Event
    April 15, 2010
    Report Date
    April 19, 2010
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    MULTIPLE PROBLEMS WITH TUBING NOT ADHERING TO CONNECTORS AND T-CONNECTORS CRACKING. FOR EXAMPLE, IN ONE CASE THE CONNECTOR WILL SEPARATE FROM THE TUBING. IN ANOTHER CASE THE CONNECTOR HUB IS CRACKING WHEN USED. THIS HAS HAPPENED MULTIPLE TIMES RECENTLY, BUT 4 TIMES WITHIN 24 HOURS WHERE THE PRODUCT HAS BEEN SAVED. WE HAVE RETAINED 6 DEFECTIVE SETS FROM TWO LOT NUMBERS. MEDRAD SAYS THEY ARE AWARE OF THE PROBLEM AND WILL PROVIDE REPLACEMENT TUBING. MEDRAD DECLINED TO TELL ME WHAT LOT NUMBERS WERE AFFECTED.THIS IS NOT A NEW PRODUCT FOR THE FACILITY. IN MOST CASES THIS OCCURRED WHILE SETTING UP THE INJECTION. NO HARM TO PATIENTS, BUT TECHNICIANS ARE CONCERNED THAT A FRAGMENT OF THE CONNECTOR COULD FALL INTO THE CONTRAST. IN ONE CASE THEY WERE NOT SURE SO THEY DISCARDED THE CONTRAST AND STARTED OVER. ====================== HEALTH PROFESSIONAL'S IMPRESSION======================DEFECTIVE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLANT DUAL SYRINGE KIT/QUICK FILL TUBE INJECTOR AND SYRINGE DXT MEDRAD, INC. * 99775 AND 99776

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES