BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILEX

    MDR report key: 698955 · Received October 3, 2005

    Report

    Report Number
    1216677-2005-00020
    Event Type
    Malfunction
    Date Received
    October 3, 2005
    Report Date
    September 30, 2005
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE IS ATTACHED TO A CANNULA TO PERFORM A D&E. AFTER THE INSERTION OF THE CANNULA, THE DOCTOR APPLIES GENTLE STEADY PRESSURE TO EVACUATE THE POC. THE HARD PLASTIC OF THE PLUNGER DETACHED FROM THE RUBBER STOPPER, CAUSING THE CANNULA TO PUSH FURTHER INTO THE UTERUS. FOUR SYRINGES FAILED THE SAME DAY. THEY WERE BEING USED BY 2 ATTENDING PHYSICIANS WITH MANY YEARS OF EXPERIENCE, ONLY 1 SYRINGE WAS SAVED. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). REFERENCE MEDWATCH 2200310000-2005-8035.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILEX SYRINGE 60CC FMF COOPERSURGICAL, INC. MS500 39608

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention