BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3853145 · Received April 2, 2014

    Report

    Report Number
    2936999-2014-00307
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 1, 2014
    Report Date
    March 7, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED FOR ANALYSIS. IF THE SAMPLE IS RECEIVED, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: DURING CUFF BALLOON TEST, THE NURSE OBSERVED THE TRACHEAL CUFF WAS TORN. THE CUSTOMER CONFIRMED NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199752 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN 201303432X

    Patients

    Seq Age Sex Outcome Treatment
    1