BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY SCT

    MDR report key: 1025142 · Received April 4, 2008

    Report

    Report Number
    2936999-2008-00165
    Event Type
    Injury
    Date Received
    April 4, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 11, 2008
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TUBE WAS DISCARDED AND THEREFORE, UNAVAILABLE FOR FAILURE INVESTIGATION. THE LOT NUMBER IS UNKNOWN. WITHOUT THE LOT NUMBER THE HISTORY RECORDS CAN NOT BE REVIEWED WITH REGARDS TO PACKAGING CONTENTS (DFU). IF THE LOT NUMBER BECOMES AVAILABLE FOR FURTHER INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ANY SIGNIFICANT INFORMATION RESULT. THE CUSTOMER HAS BEEN PROVIDED THE DFU FOR THIS TUBE. THE SCT DFU UNDER DESCRIPTION LISTS A TABLE OF AVAILABLE TUBE SIZES AND THE INNER DIAMETER OF THE TUBE IN MILLIMETERS.

    Description of Event or Problem · 1

    A PHYSICIAN WAS USING A SINGLE USE SIZE 8SCT TRACHEOSTOMY TUBE IN PLACE OF A PERCUTANEOUS TRACHEOSTOMY TUBE, AND IT CLOGGED UP AFTER A DAY OF USE. THE 8SCT TUBE WAS REMOVED AND THE PATIENT WAS IMMEDIATELY REINTUBATED. IT WAS REPORTED THE DOCTOR USES THE 8SCT TUBE IN THIS MANNER BECAUSE IT'S OUTSIDE DIAMETER (OD) IS SMALLER THAN THE SAME SIZE PERCUTANEOUS TRACHEOSTOMY TUBE. IT WAS REPORTED THAT THERE WAS NO DIRECTIONS FOR USE (DFU) IN THE 8SCT BOX. THE 8SCT TUBE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY SCT TRACHEOSTOMY TUBE BTO SCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention