BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 2840210 · Received November 14, 2012

    Report

    Report Number
    2936999-2012-00589
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 17, 2012
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTR
    PMA / PMN Number
    K873461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION NOT YET AVAILABLE. THE SAMPLE IS CURRENTLY IN TRANSIT TO THE INVESTIGATION SITE FOR ANALYSIS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CUFF WOULD NOT INFLATE DURING LASER SURGERY OF THE UPPER AIRWAY. INFO PROVIDED TO DATE DOES NOT CONFIRM ANY PT INVOLVEMENT, RESULTING IN THE NEED FOR EXTUBATION AND RECANNULATION OF A REPLACEMENT TUBE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO COLLECT FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT LASER-FLEX TRACHEAL TUBE BTR COVIDIEN/FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1