BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY PERCUTANEOUS

    MDR report key: 2190966 · Received July 28, 2011

    Report

    Report Number
    2936999-2011-00473
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 30, 2011
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTO
    PMA / PMN Number
    K884730
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK THEREFORE, THE DATE OF MFR CAN NOT BE DETERMINED. THE SAMPLE ASSOCIATED TO THIS REPORT IS CURRENTLY IN TRANSIT TO THE MFG SITE FOR INVESTIGATION. IF SIGNIFICANT INFO IS IDENTIFIED FROM THE INVESTIGATION, A SUMMARY OF THE FINDINGS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE CALLER STATED THAT THE TUBE DISCONNECTED FROM THE FLANGE. THE VENTILATOR LOW ALARM SOUNDED SINCE THE VENTILATOR COULD NOT DELIVER THE VOLUMES. THERE WAS NO DROP IN SPO2 AND NO HARM TO PT. THE CALLER STATED THAT HE THOUGHT THE TRACHEOSTOMY TUBE WAS PLACED IN THE PT AND IN MID MAY AND CHANGED IN MID JUNE. THE PT WAS RE CANNULATED WITH ANOTHER 8PERC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention