BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTED STYLET TO AID

    MDR report key: 14934938 · Received July 5, 2022

    Report

    Report Number
    MW5110695
    Event Type
    Injury
    Date Received
    July 5, 2022
    Date of Event
    June 20, 2022
    Report Date
    June 30, 2022
    Manufacturer
    UNK
    Product Code
    BSR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DISTAL PORTION OF LTA STYLET BROKEN AND LOST IN TRACHEA, REQUIRED BRONCHOSCOPY FOR REMOVAL. LTA ADMINISTERED UNDER GLIDESLOPE VISUALIZATION PRIOR TO PLACEMENT OF ETT. WITH ADMIN OF LIDOCAINE DISTAL PORTION OF LTA STYLET NOTED TO BE BROKEN/BETWEEN VC. ATTEMPT MADE AT MANUAL REMOVAL BUT BROKEN PIECE ADVANCED PAST VC AND INTO TRACHEA. DECISION MADE TO SECURE AIRWAY AND PROCEED WITH BRONCH TO RETRIEVE FOREIGN BODY. PT INTUBATED WITH GLIDE 3, 6.0NIM PLACED WITHOUT DIFFICULTY. NO DESATURATION OR VENTILATION ISSUE. BRONCH BY SURGEON CONFIRMED BROKEN STYLET IN R MAINSTEM BRONCHUS. 6.0NIM ETT EXCHANGED FOR 8.0ETT USING GLIDE 3 TO FACILITATE REMOVAL OF FOREIGN BODY WITH BRONCH. NO DESATURATIONS OR VENTILATION ISSUES THROUGHOUT. BRONCH BY SURGEON WITH SUCCESSFUL RETRIEVAL OF BROKEN STYLET. ONCE REMOVED BROKEN PIECE, EXAMINED AND IT FIT EASILY WITH REMAINING PORTION OF LTA, COMPARED TO UNBROKEN LTA STILL WITHIN PACKAGING AND NOTED TO BE SAME LENGTH - CONFIDENT THAT NO REMAINING FOREIGN BODY REMAINING WITHIN AIRWAY. ETT THEN EXCHANGED BACK TO 6.0NIM ETT FOR PROCEDURE. AS PATIENT EXPERIENCED NO IMMEDIATE COMPLICATIONS RELATING TO FOREIGN BODY, DECISION TO PROCEED WITH PLANNED PROCEDURE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2765422 LIGHTED STYLET TO AID STYLET, TRACHEAL TUBE BSR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention