BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD BC

    MDR report key: 7689627 · Received July 16, 2018

    Report

    Report Number
    7689627
    Event Type
    Malfunction
    Date Received
    July 16, 2018
    Date of Event
    June 28, 2018
    Report Date
    June 29, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CATHETER WAS LEAKING, AND WE WERE UNABLE TO SECURE TO TUBING. WE HAD TO REMOVE THE FAULTY CATHETER AND RE-STICK THE PATIENT. TWO OTHER SIMILAR CASES THIS WEEK. WE PULLED THE #20 GAUGE ANGIO CATHETERS LOT # 8003743 FROM OUR STOCK AND NOTIFIED MATERIALS MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534038 INSYTE AUTOGUARD BC CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8003743

    Patients

    Seq Age Sex Outcome Treatment
    1