BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUERLOK SYRINGE

    MDR report key: 33770 · Received June 27, 1996

    Report

    Report Number
    MW1009387
    Event Type
    Malfunction
    Date Received
    June 27, 1996
    Date of Event
    June 17, 1996
    Report Date
    June 20, 1996
    Manufacturer
    BECTON DICKINSON & CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BECTON DICKINSON AND CO. 1 BECTON DR, FRANKLIN LAKES, NJ 07417-1884. OUR INVESTIGATIONS ON THIS CONDITION INDICATE THAT THIS TYPE OF DAMAGE MAY RESULT FROM INTERNAL STRESS THAT OCCURS DURING THE MOLDING PROCESS. INTERNAL STRESS PREDISPOSES THE BARREL TO FRACTURES FROM IMPACTS THAT MAY OCCUR IN TRANSIT OR DURING HANDLING. IN USE THESE FRACTURES CAN OPEN RESULTING IN LEAKAGE. THIS CONDITION OCCURS ONLY ON A SMALL PERCENTAGE OF PARTS AND IS DIFFICULT TO DETECT. OUR RESEARCH AND DEVELOPMENT DEPT IS CURRENTLY WORKING TO IMPLEMENT AN IMPROVED SYRINGE MATERIAL THAT IS EXPECTED TO REDUCE THE FREQUENCY OF THIS DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUERLOK SYRINGE SYRINGE FMF BECTON DICKINSON & CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO