BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISION PLUS NEUTRAL IV CONNECTOR

    MDR report key: 965748 · Received December 7, 2007

    Report

    Report Number
    965748
    Event Type
    Malfunction
    Date Received
    December 7, 2007
    Date of Event
    December 1, 2007
    Report Date
    December 7, 2007
    Manufacturer
    RYMED TECHNOLOGIES, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US

    Narratives

    Description of Event or Problem · 1

    RN REPORTS SHE FOUND PATIENT'S IV TUBING DISCONNECTED FROM THE PATIENT. IT WAS NOTED THAT THE GREEN AND WHITE IV CONNECTOR CAP HAD BROKEN. CAP WAS CHANGED, STOPCOCK HAD TO BE CHANGED OUT, AS THE BROKEN PART OF THE CAP WAS STUCK INSIDE THE CONNECTOR. WE HAVE REPORTED BREAKAGE OF THIS EXACT TYPE SEVERAL TIMES. THE WHITE PLASTIC CLEARLY BREAKS AT THE THREADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISION PLUS NEUTRAL IV CONNECTOR CONNECTOR, IV, NEEDLE FREE FPA RYMED TECHNOLOGIES, INC. RYM 5000 431

    Patients

    Seq Age Sex Outcome Treatment
    1 *