BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2140495 · Received June 21, 2011

    Report

    Report Number
    2140495
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 21, 2011
    Manufacturer
    MTF
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER SYRINGE AT PLUNGER HANDLE NOTED TO BE BROKEN WHEN SURGICAL TECHNICIAN OPENED THE INNER PACKAGE. THE SYRINGE BROKE WHEN PRESSURE WAS APPLIED. THE GLASS FRAGMENTS WERE RETRIEVED AND REMOVED FROM THE FIELD. ALL PIECES WERE LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SYRINGE FMF MTF 038050 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR