BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY SCT

    MDR report key: 1034268 · Received April 25, 2008

    Report

    Report Number
    2936999-2008-00196
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 31, 2008
    Report Date
    March 31, 2008
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE TUBE IS UNK. RETURN OF THE TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE OR THE LOT NUMBER. IF THE LOT NUMBER BECOMES AVAILABLE FOR FURTHER INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ANY SIGNIFICANT INFO RESULT.

    Description of Event or Problem · 1

    THE CALLER STATED, HE WAS APPLYING A PASSE MUIR SPEAKING VALVE TO A PT'S TRACHEOSTOMY TUBE. HE DEFLATED THE CUFF OF THE TUBE, APPLIED THE VALVE AND THE PT STARTED TO COUGH AFTER A COUPLE OF MINUTES. HE FOUND THAT THE CUFF HAD REINFLATED ON ITS OWN. HE DEFLATED THE CUFF A SECOND TIME AND THE SAME THING OCCURRED. THE TRACHEOSTOMY TUBE WAS REMOVED AND REPLACED WITH A LIKE TUBE. THE TUBE WAS EXAMINED AFTER BEING REMOVED AND CALLER OBSERVED THAT THE CUFF HAD HERNIATED TOWARD THE PROXIMAL END OF THE TUBE. PART OF THE CUFF HAD PULLED AWAY FROM THE CANNULA ALLOWING AIR TO RE-ENTER THE CUFF. THE CALLER STATED, THE CUFF HAD BEEN PRETESTED PRIOR TO INSERTION. THE CUFF PRESSURES WERE KEPT BELOW 25 CM H2O.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY SCT SINGLE CANNULA TRACHEO TUBE W/CUFF BTO COVIDIEN, FORMERLY TYCO HEALTHCARE SCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention