BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EB CARLENS W/CARINA HOOK

    MDR report key: 1931154 · Received November 15, 2010

    Report

    Report Number
    8040412-2010-00080
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 27, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT BEEN RECEIVED BY MFR FOR EVALUATION; THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A F/U REPORT WILL BE SENT WHEN ADD'L INFO IS RECEIVED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE TRACHEAL CUFF OF THE BRONCHIAL TUBE DEFLATED BECAUSE THE PILOT BALLOON LEAKED. THE TUBE WAS LEFT IN. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EB CARLENS W/CARINA HOOK ENDOBRONCHIAL TUBE BTS TELEFLEX MEDICAL NA 10FE24

    Patients

    Seq Age Sex Outcome Treatment
    1