BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3123766 · Received May 14, 2013

    Report

    Report Number
    2936999-2013-00355
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 15, 2013
    Manufacturer
    COVIDIEN
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    CUSTOMER STATES: PRIOR TO USE ON A PT DURING PERFORMING PRE-TEST WITH THE DISTAL PART OF TUBE SLIGHTLY BENT, A DOCTOR CONFIRMED THE EVACUATION FAILURE OF THE CUFF. CUSTOMER CONFIRMED NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212857 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1