BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISION PLUS

    MDR report key: 775523 · Received October 10, 2006

    Report

    Report Number
    775523
    Event Type
    Malfunction
    Date Received
    October 10, 2006
    Date of Event
    October 6, 2006
    Report Date
    October 10, 2006
    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

    GREEN CAP ON IV CONNECTOR FAILED. WHITE PART PULLED APART FROM THE GREEN PART. FOUND AFTER IV WAS USED FOR EGD. PRODUCT REPLACED. NO INJURY TO PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *