BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 2903422 · Received January 2, 2013

    Report

    Report Number
    2936999-2012-00719
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    October 1, 2012
    Report Date
    December 4, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEAL, AVENIDA HENEQUEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FACILITY HAS EXPERIENCED OCCLUSION OF THE TUBE DURING PATIENT USE IN THE ICU. CUSTOMER STATES THAT THE PATIENT WAS ON A VENTILATOR AND THE VENTILATOR ALARMED AND COULD NOT VENTILATE. THE CUSTOMER REPORTED THAT EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED. THE CUSTOMER CONFIRMED THAT THE TUBE WAS REPLACED WITHOUT INCIDENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUB BTR COVIDIEN, FORMERLY TYCOHEAL, AVENIDA HENEQUEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention