BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 17744142 · Received September 14, 2023

    Report

    Report Number
    17744142
    Event Type
    Malfunction
    Date Received
    September 14, 2023
    Date of Event
    January 4, 2023
    Report Date
    June 1, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IV INSERTED TO RIGHT AC SITE WITH GOOD BLOOD RETURN. SHORTLY AFTER LEAKAGE OF IV FLUID WAS NOTED AT THE HUB AND CATHETER. IV REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390913 BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY LOT# 2280025

    Patients

    Seq Age Sex Outcome Treatment
    1 24455 DA Male