BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISION-PLUS NEUTRAL IV CONNECTOR SYSTEM

    MDR report key: 787412 · Received June 20, 2006

    Report

    Report Number
    MW1041157
    Event Type
    Malfunction
    Date Received
    June 20, 2006
    Date of Event
    June 5, 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

    THE GREEN CAP ON THE INVISION-PLUS NEUTRAL IV CONNECTOR SYSTEM WOULD NOT ATTACH TO THE WHITE PORT SECTION. NEW PIECE OBTAINED AND WORKED AS DESIGNED WITH NO FURTHER PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISION-PLUS NEUTRAL IV CONNECTOR SYSTEM INVISION PLUS NEUTRAL CONNECTOR FPA RYMED TECHNOLOGIES, INC RYM-5000 402

    Patients

    Seq Age Sex Outcome Treatment
    1 *