BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD

    MDR report key: 1080677 · Received July 11, 2008

    Report

    Report Number
    1080677
    Event Type
    Malfunction
    Date Received
    July 11, 2008
    Date of Event
    June 30, 2008
    Report Date
    July 11, 2008
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IN THE POST-ANESTHESIA RECOVERY UNIT, WHEN THEY LIFTED THEIR HAND AND A SNAP WAS HEARD. THE IV WAS NOTED TO BE LEAKING AND WAS CRACKED AT THE HUB. IV ADMINISTRATION WAS DISCONTINUED, AND THE PATIENT WAS NOT HARMED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE AUTOGUARD CATHETER, IV FOZ BECTON DICKINSON 20 GAUGE 8039726

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR