BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAT-T-INTIMA IV CATHETER

    MDR report key: 837274 · Received February 20, 2007

    Report

    Report Number
    9610847-2007-00013
    Event Type
    Malfunction
    Date Received
    February 20, 2007
    Date of Event
    January 1, 2007
    Report Date
    January 26, 2007
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE HAS BEEN RECEIVED AND IS CURRENTLY BEING DECONTAMINATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE NEEDLE SEPARATED FROM THE STYLET UPON ACTIVATION OF THE SAFETY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAT-T-INTIMA IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 6257533

    Patients

    Seq Age Sex Outcome Treatment
    1 YR