BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1862384 · Received September 21, 2010

    Report

    Report Number
    1862384
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 21, 2010
    Manufacturer
    ANGIODYNAMICS INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT SCHEDULED TO HAVE A MEDIPORT DYE STUDY FOR ASSESSMENT OF MEDIPORT. THIS STUDY WAS BEING COMPLETED DUE TO THE FACT THAT THE PARENTS, HOMECARE, AND OUTSIDE HOSPITAL WERE NOT HAVING SUCCESS WITH BLOOD RETURNS EVEN WITH INTERVENTIONS SUCH AS ALTEPASE. AFTER MEDIPORT ACCESSED AND AN IMAGE WAS TAKEN, IT WAS NOTED BY MD THAT THE CATHETER WAS DETACHED FROM THE MEDIPORT. THE TUBING AND PORT WERE REMOVED AND WAS REPLACED WITH NEW LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * CATHETER, PORT, IMPLANTED LJT ANGIODYNAMICS INC. MP-P5SAT 503882

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO