BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 CC N/S FLUSH SYRINGE

    MDR report key: 821918 · Received February 16, 2007

    Report

    Report Number
    MW1041999
    Event Type
    Malfunction
    Date Received
    February 16, 2007
    Date of Event
    February 9, 2007
    Report Date
    February 16, 2007
    Manufacturer
    *
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS MATERIAL IS RUST WHICH DEVELOPS WHEN SALINE COMES IN CONTACT WITH TINY FRAGMENTS OF FERROUS IMPURITIES EMBEDDED IN THE GASKET. THIS ISSUE HAS BEEN AROUND FOR A WHILE AND ALL FLUSH MANUFACTURERS HAVE ENCOUNTERED IT. THE OCCURRENCE OF RUST IN SYRINGE IS ABOUT ONE IN 3-5 MILLION. HOWEVER, IT MANIFESTS ITSELF IN A FORM THAT IS ALARMING. WE HAVE ALREADY HAD THIS ANALYZED AND I AM HAPPY TO SEND YOU ANALYSIS DATA FROM LABARATORIES TO SUBSTANTIATE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10 CC N/S FLUSH SYRINGE * FMF * * 0607038

    Patients

    Seq Age Sex Outcome Treatment
    1 *