BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISION PLUS

    MDR report key: 753790 · Received August 10, 2006

    Report

    Report Number
    MW1040016
    Event Type
    Malfunction
    Date Received
    August 10, 2006
    Date of Event
    July 21, 2006
    Report Date
    August 10, 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

    RN REPORTS WHILE MOVING PT'S ARM WITHOUT TENSION ON THE LINES, SHE NOTICED TUBING HAD DISCONNECTED FROM THE LINE. RN ATTEMPTED TO RECONNECT LINE BUT COULDN'T. NOTICED THE CAP ON THE PICC LINE WAS BROKEN AT THE TIP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *