BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0MM HI LO

    MDR report key: 241341 · Received September 17, 1999

    Report

    Report Number
    9681384-1999-00025
    Event Type
    Malfunction
    Date Received
    September 17, 1999
    Date of Event
    August 10, 1999
    Report Date
    September 10, 1999
    Manufacturer
    MMJ SA DE CV.
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE FACILITY REPORTED: "THREE DIFFERENT TUBES FAILED ON THREE DIFFERENT PTS IN ONE DAY. THE FACILITY IS UNSURE OF THE ACTUAL SIZES OR LOT NUMBERS OF THE TUBES INVOLVED." FACILITY SUBMITTED THE FOLLOWING LIST OF SUSPECTED LOT NUMBERS, M024860, M030650, M043600, M030150, M032960, M041440, M041420, M031040, M015530.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0MM HI LO ENDOTRACHEAL TUBE BTR MMJ SA DE CV. NA M030650

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO