BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRONCHO CATH LEFT

    MDR report key: 1130984 · Received August 20, 2008

    Report

    Report Number
    2936999-2008-00387
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 4, 2008
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    CBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNK. RETURN OF BRONCHO CATH ENDOBRONCHIAL TUBE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. NO ANALYSIS OR CONCLUSIONS CAN BE DRAWN WITHOUT THE DEVICE OR THE LOT NUMBER. IF THE ENDOBRONCHIAL TUBE IS RETURNED AND FAILURE INVESTIGATION RESULTS PROVIDE SIGNIFICANT INFO, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PRE TESTING AND INSERTING THE ENDOBRONCHIAL TUBE, THE CUFF DEFLATED. THE ENDOBRONCHIAL TUBE WAS REMOVED AND THE PT WAS RE INTUBATED. NO OTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRONCHO CATH LEFT ENDOBRONCHIAL TUBE CBI COVIDIEN/FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention