BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3061079 · Received April 9, 2013

    Report

    Report Number
    2936999-2013-00273
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    COVIDIEN/ FORMERLY TYCOHEA
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE-EVAL IN PROGRESS.

    Description of Event or Problem · 1

    CUSTOMER STATES DURING PRE-TEST PRIOR TO USE ON A PT A NURSE AT HOSPITAL CONFIRMED A PINHOLE IN TRACH CUFF. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144705 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN/ FORMERLY TYCOHEA 201210434X

    Patients

    Seq Age Sex Outcome Treatment
    1