BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2820966 · Received October 26, 2012

    Report

    Report Number
    2936999-2012-00548
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 26, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEATHCARE
    Product Code
    BTR
    PMA / PMN Number
    K082520
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE. PENDING RECEIPT OF SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT AFTER CANNULA ONE DAY USE THE 15MM CONNECTOR FELL OFF COMPLETELY AND THE CANNULA WAS STUCK IN THE PT AND HE COULD NOT VENTILATED. CUSTOMER CONFIRMED THAT EXTUBATION AND RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT SEALGUARD ENDOTRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCOHEATHCARE 201206577X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention