BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 1855228 · Received September 30, 2010

    Report

    Report Number
    1710034-2010-00049
    Event Type
    Other
    Date Received
    September 30, 2010
    Report Date
    September 17, 2010
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO DETERMINE THE ROOT CAUSE SINCE NO SAMPLE WAS RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    THEY HAD AN INCIDENT WHERE ONE OF THEIR PARAMEDICS GOT A NEEDLE STICK INJURY WHEN THE RETRACTED NEEDLE WAS PUT IN THE SHARPS CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD INSYTE AUTOGUARD INTRAVASCULAR CATHETER LJS BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other