BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3072322 · Received April 17, 2013

    Report

    Report Number
    2936999-2013-00290
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 18, 2013
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K082520
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE REPORTING PERSON, MEDICAL DEVICE OFFICER (MDO) STATED THAT A PT ARRIVED POST-SURGERY AT AROUND 13.30 AND WAS STABLE WITH GOOD BLOOD GASES. AT AROUND 15.00 THE MDO NOTICED AN AIR LEAK FROM THE TUBE AND WAS HEARD FROM THE NOISE. THE REPORTER CONFIRMED THE PT WAS STABLE. ON ADVICE OF THE END PHYSICIAN, THE PT WAS EXTUBATED AND REINTUBATED WITH A NEW TUBE. THE REPORTER STATED WHEN THE TUBE WAS EXAMINED, A HOLE IN THE PILOT BALLOON LINE WAS OBSERVED. NO FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165449 MALLINCKRODT SEALGUARD EVAC ENDOTRACHEAL BTR COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention