BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 2080072 · Received April 6, 2011

    Report

    Report Number
    2936999-2011-00243
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 8, 2011
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK THEREFORE, THE DATE OF MFR CAN NOT BE DETERMINED. THE TUBE WAS UNAVAILABLE FOR FAILURE INVESTIGATION. THE MODEL IS UNK THEREFORE, 510(K) CANNOT BE DETERMINED. NO ANALYSIS OR CONCLUSIONS CAN BE MADE WITHOUT THE DEVICE OR THE LOT NUMBER. INFO HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE CALLER REPORTED, SHE WAS AWARE THAT THE INNER CANNULA TO THE TRACH TUBE CAN UNCLIP WHEN THERE IS TORQUE PLACED ON THE HUB. SHE REPORTED THAT THE EQUIPMENT GETS HEAVY AND THE WEIGHT IS SUFFICIENT TO DISLODGE THE INNER CANNULA. SHE REPORTED, THE INNER CANNULA WAS NOT ONLY UNCLIPPED BUT PULLED OUT PART WAY AND TWISTED (AGAIN, BY THE WEIGHT OF EQUIPMENT TO WHICH IT IS ATTACHED). THE CALLER COULD NOT PROVIDE ANY SPECIFIC PT EVENT INFO WHERE MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO SAMPLE AVAILABLE AND THE CALLER DID NOT HAVE A LOT NUMBER OR THE MODEL AND SIZE OF A TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY TRACHEOSTOMY TUBE BTO COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1