BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAFLEX EMPTY IV CONTAINER

    MDR report key: 34101 · Received July 12, 1996

    Report

    Report Number
    MW1009484
    Event Type
    Malfunction
    Date Received
    July 12, 1996
    Report Date
    July 11, 1996
    Manufacturer
    I.V. SYSTEMS DIV. BAXTER HEALTHCARE CORP.
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    OZONE REACTS DIRECTLY WITH RUBBER TO FORM AN OZONIDE OF THE BASIC RUBBER HYDROCARBON, YIELDING A WHITISH BLUSH ON THE SURFACE KNOWN AS FROST 5-6. FINALLY, THESE ANTIDEGRADANTS ARE NOT A CURE-ALL FOR POLYMER AGE RESISTANCE PROBLEMS, THEY MERELY EXTEND THE SERVICEABLE LIFE OF THE COMPOUND. WITHIN HTE PRACTICAL LIMITATIONS OF RUBBER COMPOUNDING, IT IS FOR INSTANCE NOT POSSIBLE TO GIVE HIGHLY UNSATURATED NATURAL RUBBER THE SAME OZONE RESISTANCE AS IT INHERENT IN TOTALLY SATURATED ETHYLENE-PROPYLENE RUBBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIAFLEX EMPTY IV CONTAINER EMPTY IV CONTAINER, 250 ML KPE I.V. SYSTEMS DIV. BAXTER HEALTHCARE CORP. 250 ML

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO