BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISION PLUS

    MDR report key: 813176 · Received January 17, 2007

    Report

    Report Number
    813176
    Event Type
    Malfunction
    Date Received
    January 17, 2007
    Date of Event
    December 24, 2006
    Report Date
    January 16, 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

    RYMED INVISION PLUS IV CONNECTOR HAS A DEFECT. GREEN PORT TIP IS ACTUALLY "BULB-LIKE" RATHER THAN FLAT. PRODUCT IS AVAILABLE FOR EVALUATION. NOT USED. DEFECT VERY OBVIOUS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 *