BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 89388 · Received April 29, 1997

    Report

    Report Number
    1710034-1997-00014
    Event Type
    Malfunction
    Date Received
    April 29, 1997
    Date of Event
    February 1, 1997
    Report Date
    February 17, 1997
    Manufacturer
    BECTON DICKINSON VASCULAR ACCESS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEEDLE STICK OCCURRED IN THE LABOR AND DELIVERY DEPARTMENT DUE TO NEEDLE RETRACTION FAILURE. WHEN THE NEEDLE FAILED TO RETRACT THE R.N. PLACED THE UNIT WITH THE EXPOSED NEEDLE DOWN ON THE BED THAT IS WHEN THE NEEDLE STICK OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE AUTOGUARD PERIPHERAL VENOUS ACCESS CATHETER FOZ BECTON DICKINSON VASCULAR ACCESS, INC. NA C6PA130

    Patients

    Seq Age Sex Outcome Treatment
    1 *