BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA

    MDR report key: 3042053 · Received April 8, 2013

    Report

    Report Number
    3042053
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL REPORTER WAS SETTING UP MEDRAD AVANTA INJECTOR AND THE MULTI-PATIENT SYRINGE WAS TOO BIG FOR THE SYRINGE HOLDER.THE SYRINGE IS SUPPOSED TO BE FITTED FOR THE HOLDER. WHEN WE CALLED MANUFACTURER, THEY SAID IT WAS A KNOWN ISSUE AND THEY DON'T HAVE A RESOLUTION IN PLACE YET.======================MANUFACTURER RESPONSE FOR MEDRAD AVANTA INJECTOR, AVANTA (PER SITE REPORTER).======================WHILE CLEANING AT THE MANUFACTURING PLANT, SOMEONE CLEANED THE MOLD AND THE SIZE WAS ALTERED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?THE SYRINGE IS FITTED FOR THE HOLDER. WHEN CALLED MANUFACTURER IT WAS A KNOWN ISSUE, THEY DON'T RESOLUTION IN PLACE YET.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143798 AVANTA INJECTOR DXT MEDRAD, INC. * 135220

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES