BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 18020272 · Received October 27, 2023

    Report

    Report Number
    18020272
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Date of Event
    October 2, 2023
    Report Date
    October 4, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BD INSYTE AUTOGUARD 18GA X1.16 IN JELCO DID NOT PREVENT BLOOD FROM EXITING THE CATHETER. PRODUCT HAS BLOOD CONTROL TECHNOLOGY. LOT 3192236, EXP 6/30/26, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701193 BD INSYTE AUTOGUARD CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 382544 3192236

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown