BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5F BETA-CATH SYSTEM

    MDR report key: 448915 · Received March 14, 2003

    Report

    Report Number
    1062385-2003-00006
    Event Type
    Malfunction
    Date Received
    March 14, 2003
    Date of Event
    March 5, 2003
    Report Date
    March 14, 2003
    Manufacturer
    NOVOSTE CORP.
    Product Code
    MOU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE SOURCES WERE NO LONGER CONTAINED WITHIN A CLOSED SYSTEM. ALL RADIOACTIVE MATERIALS WERE POSITIVELY ACCOUNTED FOR. NO ADVERSE PATIENT OR USER EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5F BETA-CATH SYSTEM TRANSFER DEVICE AND CATHETER MOU NOVOSTE CORP. A1732 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *