BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY PERCUTANEOUS

    MDR report key: 1132584 · Received August 22, 2008

    Report

    Report Number
    2936999-2008-00407
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCHO
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE. RETURN OF THE SIZE 6 PERCUTANEOUS TRACHEOSTOMY TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. THE LOT NUMBER WAS PROVIDED AND THE MFR WILL REVIEW THE LOT HISTORY RECORDS. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE NEW OR SIGNIFICANT INFO, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT A DR STATED HE HAD INSERTED A SHILEY SIZE 6 PERCUTANEOUS TRACHEOSTOMY TUBE INTO A PT WHO DEVELOPED DIFFICULTY BREATHING. THE TUBE WAS REMOVED AND ANOTHER TUBE WAS INSERTED. THE DR STATED ON EXAMINATION OF THE TUBE THE DISTAL RIM OF THE TUBE WAS MISS-SHAPED AND ALMOST CRIMPED. THE STATED THAT IT WAS ALMOST A FIGURE 8 SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY PERCUTANEOUS TRACHOSTOMY TUBE BTO COVIDIEN/FORMERLY TYCHO 0802000796

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention