BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 3337692 · Received September 4, 2013

    Report

    Report Number
    2936999-2013-00646
    Event Type
    Injury
    Date Received
    September 4, 2013
    Date of Event
    July 1, 2013
    Report Date
    August 5, 2013
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN IS ATTEMPTING TO GATHER FURTHER DETAILS ASSOCIATED TO THIS REPORT. IF THE SAMPLE BECOMES AVAILABLE THE RESULTS OF THE SAMPLE ANALYSIS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: THAT THE TUBE PRESENTED A OCCLUSION DURING PATIENT USE AND REPORTED THAT EXTUBATION AND REINTUBATION OF A REPLACEMENT TUBE WAS REQUIRED. COVIDIEN IS ATTEMPTING TO COLLECT FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES RELATED TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439814 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUBE BTR COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention