BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5F ALPHA IV REV 2 40MM ACTIVE TRANSFER DEVICE

    MDR report key: 448550 · Received March 11, 2003

    Report

    Report Number
    1062385-2003-00005
    Event Type
    Malfunction
    Date Received
    March 11, 2003
    Date of Event
    February 20, 2003
    Report Date
    March 11, 2003
    Manufacturer
    NOVOSTE CORP.
    Product Code
    MOU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT REPORTED THAT AFTER THE VBT PROCEDURE, THE CATHETER WAS DISCONNECTED AND DISCARDED. AT THAT TIME, THE DOSE CALIBRATION WAS DONE AND A SIGNIFICANT DECREASE WAS NOTICED. THE SOURCES WERE NO LONGER CONTAINED WITHIN A CLOSED SYSTEM. ONE RADIOACTIVE SEED WAS FOUND ON THE FLOOR AND THE OTHERS WERE FOUND IN THE BAIL OUT BOX. ALL RADIOACTIVE SOURCES WERE POSITIVELY ACCOUNTED FOR AND PLACED IN THE SEED CUP CONTAINER. NO ADVERSE PATIENT OR USER EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5F ALPHA IV REV 2 40MM ACTIVE TRANSFER DEVICE TRANSFER DEVICE MOU NOVOSTE CORP. A1733 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *