BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR

    MDR report key: 4208828 · Received October 20, 2014

    Report

    Report Number
    4208828
    Event Type
    Malfunction
    Date Received
    October 20, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 20, 2014
    Manufacturer
    MICROMEDICS, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DUPLO TIP WAS BEING USED TO EJECT TISSEEL AND IT WOULD NOT EJECT. UNSURE WHAT PRODUCT FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666820 BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR SYRINGE, PISTON FMF MICROMEDICS, INC. 5MMX32CM 131213

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR FIBRIN SEALANT TISSEEL.