BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIPLE EXTENSION SET WITH BACKCHECK VALVES

    MDR report key: 7052346 · Received November 22, 2017

    Report

    Report Number
    MW5073513
    Event Type
    Malfunction
    Date Received
    November 22, 2017
    Date of Event
    November 19, 2017
    Report Date
    November 20, 2017
    Manufacturer
    CODAN US CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FLUIDS WERE STOPPED AND IV TUBING WAS DISCONNECTED FROM PATIENT IN PREPARATION TO CHANGE CLAVE ON PORT BEFORE BEGINNING TPN AND LIPIDS. WHEN TRI-FUSE WAS DISCONNECTED, IT WAS DISCOVERED THAT THE MALE PORTION HAD COMPLETELY BROKEN OFF AND WAS STUCK INSIDE THE CLAVE. CAP AND TUBING WERE REPLACED. TUBING AND CLAVE SAVED FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833678 TRIPLE EXTENSION SET WITH BACKCHECK VALVES SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORPORATION BC 586 72289

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR