BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3080679 · Received March 28, 2013

    Report

    Report Number
    3080679
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 27, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT WITH DIAGNOSIS OF ACUTE MI AND WAS INTUBATED BY THE ATTENDING EMERGENCY TECHNICIAN AND APPROXIMATELY WITHIN 14 MINUTES THE PT HAD TO BE REINTUBATED DUE TO AIR LEAK. THE SECOND INTUBATION WAS ASSESSED BY RESPIRATORY AND ADVANCED 3 CM AND THE AIR LEAK CONTINUED EVEN WHEN TAKEN OFF THE VENT AND BAGGED. THE ANESTHESIOLOGIST WAS CONSULTED AND THEY ADVANCED THE ETT TUBE TO 26 CM AND THE LEAKING CEASED. COVIDIEN IS ATTEMPTING TO GATHER FURTHER DETAILS RELATED TO THIS REPORT. REFERENCE MFR REPORT # 2936999-2013-00229.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129588 MALLINCKRODT HI-LOW TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCO HEALTHCARE 120600185X

    Patients

    Seq Age Sex Outcome Treatment
    1