BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE-STAT

    MDR report key: 17270 · Received October 28, 1994

    Report

    Report Number
    MW1003851
    Event Type
    Injury
    Date Received
    October 28, 1994
    Date of Event
    October 25, 1994
    Report Date
    October 25, 1994
    Manufacturer
    XOMED TREACE, INC.
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ITEM IS PACKAGED WITH VINYL RING SLEEVE AROUND LIGHT BULB (TO PROTECT BULB). THE SLEEVE WAS NOT REMOVED BY THE OPERATOR PRIOR TO THE ORAL INTUBATION STYLET'S INTRODUCTION INTO THE LUMEN OF A 7.5 ID ENDOTRACHEAL TUBE. UPON REMOVAL OF THE INTUBATION STYLET THE VINYL RING SLEEVE BALLED UP IN THE ENDOTRACHEAL TUBE OCCLUDING THE LUMEN. THIS IS A POTENTIALLY LIFE-THREATENING PROBLEM. OF RELATED CONCERN IS THAT THIS SLEEVE MAY FALL OFF THE STYLET AND ENTER THE TRACHEOBRONCHIAL TREE. THE VINYL RING SLEEVE (COLLAR) AS PACKAGED IS COLORLESS AND EASILY OVERLOOKED. IT MAY BE REASONABLE TO SUGGEST TO THE MFR TO COLOR-CODE THE PROTECTIVE SLEEVE, OR TO PACKAGE THE INSTRUMENT SO THAT THE LIGHT BULB IS CUSHIONED INTO THE PACKAGING MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUBE-STAT ORAL INTUBATION STYLET BSR XOMED TREACE, INC. 83-30400 81166 00

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention