BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLEX GS

    MDR report key: 221461 · Received April 30, 1999

    Report

    Report Number
    MW1016227
    Event Type
    Malfunction
    Date Received
    April 30, 1999
    Report Date
    April 30, 1999
    Manufacturer
    MILLIPORE CORP.
    Product Code
    JRL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RPTR WORKS FOR A MFR THAT USES THE FILTERS IN THEIR PROCESSING OF F18 FDG, WHICH IS USED DURING POSITRON EMISSION TOMOGRAPHY. THE CO'S END PRODUCT WAS DETERMINED AS PYROGENIC FOR A PERIOD OF SEVERAL MONTHS. AFTER RESEARCH AND TESTING, THE CAUSE OF THE PYROGENIC END PRODUCT WAS DETERMINED TO BE FILTERS FROM THE REPORTED LOT NUMBER. THE RPTR STATES THAT THE CO INFORMED ALL OF THEIR SITES TO STOP USING THE FILTERS FROM THAT LOT. THE RPTR CLAIMS THAT THE FIRM HAS USED THESE FILTERS IN THEIR MFG PROCESS FOR "SOME TIME", AND THIS EVENT HAS BEEN ISOLATED TO THE LOT NUMBER IN QUESTION. SINCE THE RPTR'S PRODUCT IS TESTED THOROUGHLY PRIOR TO DISTRIBUTION, ALL THE PRODUCTS AFFECTED WERE NOT DISTRIBUTED FOR USE. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLEX GS MILLIPORE FILTER JRL MILLIPORE CORP. * R8EM78710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA