BEUDAMED
    FDA Adverse Event Summary report: N

    VIAFLEX CONTAINER, 150 ML

    MDR report key: 20168 · Received March 7, 1995

    Report

    Report Number
    MW1005358
    Date Received
    March 7, 1995
    Date of Event
    January 1, 1995
    Report Date
    February 23, 1995
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KPE
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    BAXTER HEALTHCARE CORP. RT 120 & WILSON RD. ROUND LAKE, IL 60073-0490. A WHITE IRREGULAR SHAPED PARTICLE, APPROX 3.6 MM IN SIZE WAS OBSERVED IN THE ADMINISTRATION PORT OF THE CONTAINER. THE PARTICLE WAS IDENTIFIED AS POLYETHYLENE PLASTIC. THE ORIGIN OF THE MATERIAL COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIAFLEX CONTAINER, 150 ML CONTAINER KPE BAXTER HEALTHCARE CORP. P051128

    Patients

    Seq Age Sex Outcome Treatment
    1 *