BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 4228343 · Received November 5, 2014

    Report

    Report Number
    2936999-2014-00948
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 8, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTO
    PMA / PMN Number
    K811447
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTS FOR INFORMATION AND DISPOSITION OF DEVICES FOR RETURN FOR EVALUATION HAVE BEEN MADE BY COVIDIEN. (B)(4)

    Additional Manufacturer Narrative · 1

    THE REPORTER STATED THAT THE PATIENT IS "DOING FINE", AND HAS HAD NO FURTHER COMPLAINTS ABOUT THE PREVIOUSLY REPORTED 'IRRITATION". REPORTER HAD ORIGINALLY INDICATED THAT THE DEVICE WOULD BE RETURNED FOR EVALUATION, AND NOW STATES THAT THE DEVICE WILL NOT BE RETURNED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT FROM A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER THAT ONE OF THEIR HOME PATIENTS WAS EXPERIENCING AIRWAY IRRITATION,DISCOMFORT,COUGHING AND SOME BLEEDING AFTER INSERTING AND USING A DISPOSABLE INNER CANNULA(DIC) FROM A NEW BOX. THE PATIENT HAD INDICATED THAT THE DIC PROTRUDED FROM THE END OF HER TRACHEOSTOMY TUBE AND CAUSED HER SYMPTOMS. THE PATIENT THEN REPLACED THAT TRACH TUBE WITH A SPARE TUBE SHE HAD AT HOME, RETURNED THAT TRACHEOSTOMY TUBE IN USE AT TIME OF REPORT AND A SAMPLE OF DIC TO THE DME OFFICE. THE DME MANAGER SENT THE PATIENT HOME WITH AN ALTERNATE NEW BOX OF DISPOSABLE INNER CANNULAS. THE PATIENT DID NOT REQUIRE A PHYSICIAN VISIT FOR THE ISSUE PER THE DME AND HAS NOT CALLED BACK WITH ANY ADDED COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710509 SHILEY TRACHEOSTOMY TUBE BTO COVIDIEN 6DCFS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHILEY TRACHEOSTOMY TUBE