BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BOUGIE TIP

    MDR report key: 4379913 · Received December 30, 2014

    Report

    Report Number
    MW5039892
    Event Type
    Injury
    Date Received
    December 30, 2014
    Date of Event
    December 2, 2014
    Report Date
    December 18, 2014
    Manufacturer
    SUNMED, INC.
    Product Code
    BTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADVERSE PT EVENT INVOLVING A BOUGIE TIP (USED FOR INTUBATION) THAT BROKE INSIDE OF PT, LODGED IN LUNG, REQUIRED BRONCHOSCOPY AT BEDSIDE WITH PROLONGED INTENSIVE CARE AND HOSPITALIZATION. ON (B)(6) 2014, REINTUBATION REQUIRED DUE TO ETT CUFF NOT REMAINING INFLATED. ON (B)(6) 2014: CHEST X-RAY REVEALS COMPLETE OPACIFICATION OF LEFT LUNG DUE TO OBSTRUCTION OR POSSIBLE MUCOUS PLUG; UNPLANNED EMERGENT BEDSIDE BRONCHOSCOPY COMPLETED IN MEDICAL INTENSIVE CARE UNIT. MICU STAFF UNAWARE OF INTRODUCER TIP BREAKING; FOREIGN BODY RETRIEVED FROM LUNG DURING BRONCHOSCOPY; FAMILY MEMBERS STATE PT CHEWING ON SEWING RIPPING TOOL AT HOME AND LOOKED LIKE THE TIP OF SEWING TOOL. ON (B)(6) 2014: MICU STAFF MEMBER SUGGESTS FOREIGN BODY COULD HAVE BEEN BOUGIE TIP AND INVESTIGATION BEGINS WITH CERTAIN AWARENESS THAT FOREIGN BODY IS BOUGIE TIP. ON (B)(6) 2014: BOUGIE TIP INSPECTED HOSPITAL WIDE AND DISCOVERED SPECIFIC LOT OF BOUGIE MEDICAL DEVICES HARDENED AND CAN BE BROKEN WHILE IN STERILE PACKAGING; INVENTORY REMOVED AND SENTINEL EVENT ROOT CAUSE ANALYSIS INITIATED. PT REMAINS HOSPITALIZED WITH NOTED DAILY IMPROVEMENT AND FUTURE DISCHARGE PLANNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858213 BOUGIE TIP ENDOTRACHEAL TUBE INTRODUCER BTR SUNMED, INC. 15FR X70CM MD070 4/20/16

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R