BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODIT

    MDR report key: 2903430 · Received January 2, 2013

    Report

    Report Number
    2936999-2012-00726
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 7, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTH, 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. THE CUSTOMER REPORTED THAT EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032 MALLINCKRODIT TAPERGUARD ORAL/NASAL TRACHEAL TUB BTR COVIDIEN, FORMERLY TYCO HEALTH, AVENIDA HENEQUEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention