BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY LOW PRESSURE CUFFED

    MDR report key: 2010497 · Received March 1, 2011

    Report

    Report Number
    2936999-2011-00099
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 4, 2011
    Manufacturer
    COVIDIEN FORMERLY TYCO
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT NUMBER PROVIDED WILL BE REVIEWED. A FAILURE INVESTIGATION WILL BE PERFORMED ON THE RETURNED SAMPLE. IF SIGNIFICANT INFO IS OBTAINED FROM THE INVESTIGATION, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECANNULATED THE PT WITH A SIZE 10LPC TRACHEOSTOMY TUBE DUE TO A LEAK IN THE SIZE 8 LPC TRACHEOSTOMY TUBE. AFTER INSERTION THERE WAS A LEAK AROUND THE CONNECTION WITH THE OUTER TUBE OF THE SIZE 10 LPC AND THE PT WAS RECANNULATED SUCCESSFULLY WITH A THIRD UNSPECIFIED SIZE AND MODEL OF TRACHEOSTOMY TUBE. THE FIRST EVENT REGARDING THE 8LPC HAS BEEN REPORTED ON REPORT NUMBER 2936999-2011-00098.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY TUBE JOH COVIDIEN FORMERLY TYCO 1005001369

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention