BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALPHA IV REV.2, 40MM ACTIVE TRANSFER DEVICE

    MDR report key: 441980 · Received January 31, 2003

    Report

    Report Number
    1062385-2003-00001
    Event Type
    Malfunction
    Date Received
    January 31, 2003
    Date of Event
    January 10, 2003
    Report Date
    January 31, 2003
    Manufacturer
    NOVOSTE CORP.
    Product Code
    MOU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT MANAGER REPORTED TO NOVOSTE THAT THE "RSO" HAD DETACHED THE BETA-CATH DELIVERY CATHETER BEFORE ALL THE SOURCES WERE RETRIEVED BACK INTO THE TRANSFER DEVICE. ALL RADIOACTIVE MATERIAL WAS POSITIVELY ACCOUNTED FOR. NO ADVERSE PT EVENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *