BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXYGEN TUBING

    MDR report key: 2199234 · Received August 3, 2011

    Report

    Report Number
    2199234
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 3, 2011
    Manufacturer
    WESTMED, INC.
    Product Code
    BYX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US

    Narratives

    Description of Event or Problem · 1

    STAFF WAS GETTING SUPPLIES READY FOR PROCEDURE AND NOTICED A SMALL OBJECT LOCATED INSIDE THE OXYGEN TUBING. OBJECT APPEARS TO BE A MELTED BEAD OF GLUE OR TUBING MATERIAL THAT IS LIGHT BROWN IN COLOR. TUBING WAS NEVER USED ON PATIENT AND OTHER SUPPLIES FROM THE SAME LOT NUMBER WERE CHECKED AND NO SIMILAR DEFECTS WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXYGEN TUBING TUBING, PRESSURE AND ACCESSORIES BYX WESTMED, INC. 0008 0104103N

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES