BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTO GUARD

    MDR report key: 93788 · Received May 22, 1997

    Report

    Report Number
    1710034-1997-00018
    Event Type
    Malfunction
    Date Received
    May 22, 1997
    Date of Event
    April 1, 1997
    Report Date
    April 25, 1997
    Manufacturer
    BECTON DICKINSON VASCULAR ACCESS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEEDLE STICK INJURY OCCURRED DUE TO NEEDLE RETRACTION FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE AUTO GUARD PERIPHERAL VENOUS ACCESS CATHETER FOZ BECTON DICKINSON VASCULAR ACCESS, INC. NA C6BA400,C7AA400

    Patients

    Seq Age Sex Outcome Treatment
    1 *