BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED STREAM

    MDR report key: 2901701 · Received January 3, 2013

    Report

    Report Number
    MW5028437
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 24, 2012
    Manufacturer
    MEDICARE SPECIALTIES DISTRIBUTORS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS HAS THE SAME PRODUCT NUMBER AS OUR OTHER EXTENSIONS ALTHOUGH THEY ARE NOT THE SAME AND THIS ONE LEAKS ON HUB. I HAVE HAD SIX COMPLAINTS ON SEPARATE OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3286 MED STREAM 12" EXTENSION SET FPA MEDICARE SPECIALTIES DISTRIBUTORS 20121005

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR