BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSTREAM (PRIVATE LABEL)

    MDR report key: 276955 · Received May 3, 2000

    Report

    Report Number
    MW1018831
    Event Type
    Malfunction
    Date Received
    May 3, 2000
    Date of Event
    May 1, 2000
    Report Date
    May 3, 2000
    Manufacturer
    MEDICAL SPECIALTIES DISTRIBUTOR, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SECOND INCIDENT WITH THIS PRODUCT. INSERTION IS OKAY. UPON REMOVAL THE SKIN AND TISSUE ARE TORN. APPEARS THE NEEDLE END IS BENT OR A "BURR". TWO DAYS LATER RECEIVED CALL FROM SAME LOCATION STATING THAT THEY CHECKED THE PRODUCT PRIOR TO INSERTION AND NOTED THAT THE NEEDLE TIP APPEARED TO BE BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDSTREAM (PRIVATE LABEL) NEEDLE - HUBER 196 X 3 1/4 FMI MEDICAL SPECIALTIES DISTRIBUTOR, INC. * 99E2J

    Patients

    Seq Age Sex Outcome Treatment
    1 *