BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 2800089 · Received October 17, 2012

    Report

    Report Number
    2936999-2012-00537
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 19, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE ASSOCIATED WITH THIS REPORT IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT DURING OPERATING ROOM PREPARATION PRIOR TO THE ANESTHESIA INDUCTION, IT IS OBSERVED THAT THE TUBE HAS A PROBLEM WITH THE PILOT BALLOON. CUSTOMER STATED IT INFLATED WITH NO PROBLEM BUT COULD NOT BE EMPTIED USING THE SYRINGE. CUSTOMER CONFIRMED THIS WAS IDENTIFIED DURING OPERATING ROOM PREPARATION AND NOT DURING PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1