BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY LOW PRESSURE CUFFED

    MDR report key: 1101801 · Received August 6, 2008

    Report

    Report Number
    2936999-2008-00346
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN OF THE LOW PRESSURE CUFFED 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 SIGNIFICANT INFO, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAK BETWEEN THE INNER AND OUTER CANNULA. THE PT COULD NOT BE VENTILATED AND THE TUBE WAS REMOVED. NO OTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE BTO COVIDIEN/FORMERLY TYCO HEALTHCARE 0705000830

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention