BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNMED

    MDR report key: 4469330 · Received December 29, 2014

    Report

    Report Number
    4469330
    Event Type
    Injury
    Date Received
    December 29, 2014
    Date of Event
    December 2, 2014
    Report Date
    December 24, 2014
    Manufacturer
    SUNMED INC.
    Product Code
    BSR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADVERSE PATIENT EVENT INVOLVING A BOUGIE TIP (USED FOR INTUBATION) THAT BROKE INSIDE OF PATIENT, 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. ON (B)(6) 2014 - UNPLANNED EMERGENT BEDSIDE BRONCHOSCOPY COMPLETED IN MEDICAL INTENSIVE CARE UNIT; MICU STAFF UNAWARE OF INTRODUCER TIP BREAKING. ON (B)(6) 2014 - FOREIGN BODY RETRIEVED FROM LUNG DURING BRONCHOSCOPY. ON (B)(6)2014 - FAMILY MEMBERS STATE PATIENT 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 TIPS 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. MFR REF# 2183650-2014-00006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856572 SUNMED ENDOTRACHEAL TUBE INTRODUCER BSR SUNMED INC. 15FR X70CM MD070

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R