BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 1911419 · Received November 23, 2010

    Report

    Report Number
    1710034-2010-00061
    Event Type
    Other
    Date Received
    November 23, 2010
    Date of Event
    October 6, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED. SAMPLE HAS BEEN RECEIVED AND IS CURRENTLY BEING DECONTAMINATED. FOLLOWING COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    DEVICE INSERTED AND NEEDLE DID NOT RETRACT, RESULTING IN A NEEDLE STICK INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK