BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODAN

    MDR report key: 8715724 · Received June 20, 2019

    Report

    Report Number
    8715724
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    May 24, 2019
    Report Date
    June 18, 2019
    Manufacturer
    CODAN US CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AFTER THE NURSE PLACED THE IV AND CONNECTED THE IV FLUIDS, THE NURSE NOTICED THAT THERE WAS BLOOD BACKING UP IN THE TUBING FROM THE PATIENT'S PIV. ALL CONNECTIONS WERE TIGHT. THE NURSE THEN OPENED THE ROLLER CLAMP FULLY IN ORDER TO FLUSH THE LINE. THE NURSE FELT SOMETHING WET ON MY SCRUBS. UPON FURTHER INSPECTION OF THE TUBING, IT WAS NOTED THAT THE IV FLUID WAS SQUIRTING OUT FROM ONE OF THE VALVES ON THE IV TUBING. THE NURSES IN THIS AREA HAVE HAD PROBLEMS WITH THIS BRAND OF TUBING REGARDING LOOSE CONNECTIONS AND ROLLER CLAMP STIFFNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514093 CODAN SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORPORATION B 2024-W 78109

    Patients

    Seq Age Sex Outcome Treatment
    1 18980 DA