BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAXTER STERILE WATER FOR IRRIGATION

    MDR report key: 2103297 · Received May 20, 2011

    Report

    Report Number
    2103297
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LWD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    SPD (STERILE PROCESSING AND DISTRIBUTION) TECHNICIAN OBSERVED A BLACK MATERIAL OF UNKNOWN ORIGIN AND COMPOSITION ON THE INSIDE WALL OF THE PLASTIC IRRIGATING SOLUTION CONTAINER (PLASTIC BOTTLE). THE MATERIAL WAS 1 MM X 2 MM ROUGHLY ELLIPTICAL IN SHAPE WITH TWO SMALL PROJECTIONS EXTENDING AWAY FROM THE CENTRAL MASS. THE MATERIAL ADHERED TO THE INNER WALL OF THE BOTTLE. THERE WAS ALSO A SLIGHT IRREGULARITY IN THE PLASTIC WALL OF THE BOTTLE. IT APPEARED TO BE A 9 MM CREASE IN THE WALL OF THE BOTTLE ENDING IN AT THE UNKNOWN BLACK MATERIAL. EXAMINATION OF OTHER UNITS OF THE SAME LOT NUMBER DID NOT REVEAL ANY OTHER SIMILAR DEFECTS.======================MANUFACTURER RESPONSE FOR IRRIGATION SOLUTION, BAXTER STERILE WATER FOR IRRIGATION (PER SITE REPORTER)======================LEFT MESSAGE FOR REPRESENTATIVE IN PRODUCT SURVEILLANCE DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER STERILE WATER FOR IRRIGATION IRRIGATION SOLUTION LWD BAXTER HEALTHCARE CORPORATION * G094300

    Patients

    Seq Age Sex Outcome Treatment
    1 *