BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC 20GA

    MDR report key: 20733618 · Received November 20, 2024

    Report

    Report Number
    20733618
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    August 17, 2024
    Report Date
    August 23, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    20 GA IV CATHETER SHOWED SIGNS OF LEAKING WHERE THE CATHETER TUBE MEETS THE PLASTIC HUB. I WAS ABLE TO ACCESS THE PATIENT'S VEIN GREAT AND WHEN I BEGAN TO TEST FLUSH WITH SALINE, BY HAND, I NOTICED THE LEAK. WHEN I DREW BACK ON THE SALINE FLUSH YOU CAN SEE TINY AIR BUBBLES AND ACTUALLY HEAR THE AIR IN THE LINE. I REMOVED THE IV AND UNFORTUNATELY HAD TO START A NEW ONE. THE LOT NUMBER IS 4093240, EXP 2027-03-31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2481282 BD INSYTE AUTOGUARD BC 20GA CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 382533 4093240

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown