BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH CATHETER SYSTEM

    MDR report key: 609602 · Received July 8, 2004

    Report

    Report Number
    1710034-2004-00045
    Event Type
    Malfunction
    Date Received
    July 8, 2004
    Date of Event
    February 27, 2004
    Report Date
    March 18, 2004
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CATHETER PLACED IN 2004, ATTEMPTED TO IRRIGATE DIFFICULTY NOTED BUT SOME SLIGHT MOVEMENT. ASPIRATE AND IRRIGATE WHEN FLUID NOTED A HAB. SWABBED AND CHECKED LINE AGAIN AND CLEAR HUB HAD BLOWN OFF OF YELLOW STRAIN RELIEF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH CATHETER SYSTEM PERCUTANEOUS CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN