BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISION-PLUS JUNIOR

    MDR report key: 1413331 · Received July 7, 2009

    Report

    Report Number
    1413331
    Event Type
    Malfunction
    Date Received
    July 7, 2009
    Date of Event
    June 26, 2009
    Report Date
    July 7, 2009
    Manufacturer
    RYMED TECHNOLOGIES, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE INVISION-PLUS JUNIOR IV CONNECTOR SEPARATED AT THE WHITE AND BLUE COMPONENTS (FEMALE LUER AND SPIKE BODY). THE DEVICE WAS FOUND LAYING IN PIECES IN THE BED WHERE A LARGE AMOUNT OF IV FLUID WAS FOUND. MANUFACTURER RESPONSE (AS PER REPORTER) FOR IV CONNECTOR, INVISION-PLUS JUNIOR:THE DEVICE WAS EVALUATED AND IT WAS CONFIRMED THAT THE UNIT HAD SEPARATED AT THE WELD AREA. THERE WAS EVIDENCE OF MATERIAL TRANSFER WHICH INDICATES THAT THE SAMPLE HAD GONE THROUGH THE WELDING PROCESS. THE SAMPLE WAS THEN SENT TO THE ASSEMBLY MANUFACTURER FOR EVALUATION AND ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVISION-PLUS JUNIOR IV CONNECTOR FPA RYMED TECHNOLOGIES, INC. RYM-8001 R000065

    Patients

    Seq Age Sex Outcome Treatment
    1 0 MO