BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5F BETA-RAIL DELIVERY CATHETER

    MDR report key: 526279 · Received February 19, 2004

    Report

    Report Number
    1062385-2004-00002
    Event Type
    Malfunction
    Date Received
    February 19, 2004
    Date of Event
    January 21, 2004
    Report Date
    February 19, 2004
    Manufacturer
    NOVOSTE CORP.
    Product Code
    MOU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    AFTER SUCCESSFUL COMPLETION OF THE PROCEDURE, THE USER IDENTIFIED BLOOD IN THE FLUID COLLECTION BAG. A LEAK IN THE DISTAL SECTION OF THE CATHETER WAS IDENTIFIED AFTER THE CATHETER WAS REMOVED FROM THE PT. THE SOURCE TRAIN WAS FULLY RECOVERED WITHIN THE TRANSFER DEVICE. NO UNINTENDED RADIATION EXPOSURE WAS EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5F BETA-RAIL DELIVERY CATHETER CATHETER MOU NOVOSTE CORP. P00552 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *