BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3082600 · Received April 23, 2013

    Report

    Report Number
    2936999-2013-00312
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    COVIDIEN
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    CUSTOMER STATES: DURING PRE-TEST PRIOR TO USE ON A PT AT HOSPITABLE, A DOCTOR CONFIRMED THE AIR LEAKAGE FROM THE CUFF. NO PT INVOLVEMENT. NO FURTHER DETAILS AVAILABLE FOR THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175355 MALLINCKRODT TAPERGUARD ORAL/NASAL TRACHEAL TUBE BTR COVIDIEN 120600214

    Patients

    Seq Age Sex Outcome Treatment
    1