BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2940743 · Received January 29, 2013

    Report

    Report Number
    2936999-2013-00056
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 4, 2012
    Report Date
    January 4, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEA
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CALLER, REPRESENTATIVE OF MATERIALS MANAGEMENT, STATES THAT ON (B)(6) 2012 AT 6:00 AM IN THE ICU THE PHYSICIAN WAS PERFORMING AN EMERGENCY INTUBATION ON A PATIENT AND THEY DISCOVERED A RIP IN THE PILOT BALLOON. THE CALLER REPORTED THE TUBE HAD TO BE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39597 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUBE BTR COVIDIEN, FORMERLY TYCOHEA 120201515X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention