BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISION PLUS NEUTRAL IV CONNECTOR SYSTEM

    MDR report key: 787023 · Received June 20, 2006

    Report

    Report Number
    MW1041160
    Event Type
    Malfunction
    Date Received
    June 20, 2006
    Date of Event
    June 13, 2006
    Report Date
    June 20, 2006
    Manufacturer
    RYMED TECHNOLOGIES, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EPIDURAL PUMP KEPT READING "UPSTREAM OCCLUSION." TWO DIFFERENT NURSES ATTEMPTED TO "TROUBLE SHOOT" THE PROBLEM. FINALLY NEW TUBING, NEW PUMP, ETC ALL CHANGED OUT. THE PCA HAD BEEN INFUSING INTO A PICC LINE WITH THE GREEN NEUTRALIZING PORT. AFTER TAKING DOWN THE OLD SET THE RN NOTICED A PIECE OF GREEN PLASTIC STUCK INSIDE THE HUB OF THE PCA TUBING. IT WAS FROM THE GREEN PICC CAP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *