BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 1952320 · Received December 20, 2010

    Report

    Report Number
    1952320
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 12, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BD MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    A NURSE ATTEMPTED TO INSERT A 24 GAUGE CATHETER INTO THE PATIENT'S VEIN TO START AN IV AND WAS UNABLE TO INSERT THE DEVICE. THE NURSE NOTED THE CATHETER WAS PERPENDICULAR TO THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE AUTOGUARD CATHETER, IV, THERAPEUTIC, SHORT TERM FOZ BD MEDICAL 381412 *

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR