BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 91545 · Received April 19, 1997

    Report

    Report Number
    1710034-1997-00017
    Event Type
    Malfunction
    Date Received
    April 19, 1997
    Date of Event
    April 9, 1997
    Report Date
    April 14, 1997
    Manufacturer
    BECTON DICKINSON VASCULAR ACCESS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEEDLE STICK INJURY OCCURRED WHEN THE NEEDLE DID NOT FULLY RETRACT INTO SAFETY BARREL ON THE IV CATHETER.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other