BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XLT EXTENDED LENGTH PROXIMAL CUFFED

    MDR report key: 1101808 · Received August 6, 2008

    Report

    Report Number
    2936999-2008-00354
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 9, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF THE XLT TRACHEOSTOMY TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. THE LOT NUMBER IS UNK. NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE OR THE LOT NUMBER. IF THE TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE SIGNIFICANT INFO, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CALLER REPORTED THAT THE PT WAS BEING WEANED AND THE CUFF WAS DEFLATED AND THE TUBE WAS CAPPED. AFTER A COUPLE OF MINUTES, THE PT BECAME VERY DISTRESSED AND INDICATED THAT HE COULD NOT BREATH. THE CALLER CHECKED THE PT AND FOUND THAT THE CUFF WAS INFLATED. THE CALLER DEFLATED THE CUFF AND OBSERVED THE PT. AFTER JUST A COUPLE OF MINUTES, THE PT AGAIN BECAME DISTRESSED AND AGAIN THE CUFF WAS INFLATED. THE CALLER DISCOVERED THAT WITH EITHER A CAP OR SPEAKING VALVE ON THE TUBE THAT IT WOULD SELF INFLATE WITHIN A COUPLE OF MINUTES AND THE PT WAS NOT ABLE TO BREATH. THE TUBE WAS REMOVED AND REPLACED WITH ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XLT EXTENDED LENGTH PROXIMAL CUFFED TRACHEOSTOMY TUBE BTO COVIDIEN/FORMERLY TYCO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention