BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT-GLIDE SUB-509

    MDR report key: 5825557 · Received July 24, 2016

    Report

    Report Number
    MW5063668
    Event Type
    Malfunction
    Date Received
    July 24, 2016
    Date of Event
    July 24, 2016
    Report Date
    July 24, 2016
    Manufacturer
    EMED TECHNOLOGIES
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM REPORTING A DEFECT IN A PRODUCT OF EMED TECHNOLOGY CORPORATION - THE "SOFT-GLIDE SUB-509," A SUBCUTANEOUS INFUSION SET WITH LOT #1510066 AND AN EXPIRATION DATE OF (B)(6) 2020. I FOUND A LEAK IN ONE OF THE TUBING LINES ABOVE THE NEEDLE, BUT BELOW A TRI-FURCATION TUBING NODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471400 SOFT-GLIDE SUB-509 NEEDLE FPA EMED TECHNOLOGIES SUB-509 1510066

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR