BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 89341 · Received April 29, 1997

    Report

    Report Number
    1710034-1997-00013
    Event Type
    Malfunction
    Date Received
    April 29, 1997
    Date of Event
    March 1, 1997
    Report Date
    April 24, 1997
    Manufacturer
    BECTON DICKINSON VASCULAR ACCESS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE IV WAS PLACED, THE NURSE PUSHED THE ACTIVATION BUTTON TO RETRACT THE NEEDLE INTO THE SAFETY BARREL. SHE THEN PROCEEDED TO GET THE IV TO CONNECT TO THE HUB. THE NEEDLE RETRACTION WAS SLOWER THEN SHE ANTICIPATED, AND THE PATIENT MOVED CAUSING THE NURSE TO BE STUCK IN THE FINGER TIP BY THE CONTAMINATED NEEDLE. THE UNIT WAS NOT SAVED. THE PATIENT HAS TESTED HIV AND HEPATITIS C POSITIVE.

    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