BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY FENESTRATED LOW PRESSURE CUFFED

    MDR report key: 2040991 · Received March 25, 2011

    Report

    Report Number
    2936999-2011-00229
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 7, 2011
    Manufacturer
    COVIDIEN /FORMERLY TYCO HEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK, THEREFORE, THE DATE OF MANUFACTURE CANNOT BE DETERMINED. NO ANALYSIS OR CONCLUSIONS CAN BE MADE WITHOUT THE DEVICE. INFO HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE CALLER REPORTED THAT THE TRACHEOSTOMY TUBE HAS PINKISH/YELLOW FLUID IN PILOT BALLOON. THE CALLER STATED THAT THE TUBE HAS ONLY BEEN IN PLACE FOR 2 WEEKS. THE CUFF IS NOT INFLATED FOR VENTILATION OR ASPIRATION PRECAUTIONS. THE CALLER STATED THAT THE TUBE WILL NEED TO BE REMOVED AT THE DR'S OFFICE AND THE PT WILL NEED RECANNULATION THAT IS NOT A SCHEDULED REPLACEMENT. ON (B)(6) 2011, THE CALLER SENT AN EMAIL TO THE TECHNICAL SERVICES DEPT. FURTHER REPORTING THAT THE PT WAS INSTRUCTED TO KEEP THE TUBE, BUT THREW IT OUT WHEN IT WAS RECENTLY REPLACED. THE DATE OF THE REPLACEMENT IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY FENESTRATED LOW PRESSURE CUFFED TRACHEOSTOMY TUBE JOH COVIDIEN /FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention