BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E.T. TAPE-II

    MDR report key: 1374047 · Received February 18, 2009

    Report

    Report Number
    2938401-2009-00001
    Event Type
    Malfunction
    Date Received
    February 18, 2009
    Date of Event
    December 31, 2008
    Report Date
    February 5, 2009
    Manufacturer
    B & B MEDICAL TECHNOLOGIES, INC.
    Product Code
    CBH
    PMA / PMN Number
    K912888
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUBJECT ITEM IS A DISPOSABLE ENDOTRACHEAL TUBE FIXATION DEVICE THAT WAS CONTAMINATED BY PT'S BODILY FLUIDS AND IS NOT AVAILABLE FOR TESTING. A DEVICE FROM SAME LOT # WAS TESTED. THE 11010 E.T. (B) (4). THERE ARE NO REPORTS OF ANY PRODUCT FAILURE OF THE 11010. BASED ON THE AVAILABLE LIMITED INFORMATION, IT WOULD APPEAR THAT THE E.T. TAPE-II DEVICE MAY HAVE BEEN EXPOSED TO A FORCE THAT FAR EXCEEDED THE DESIGN. BASED UPON AVAILABLE INFORMATION, NO CORRECTIVE ACTION APPEARS TO BE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    NURSE WAS TURNING PT IN ROTATING HOSPITAL BED, A POPPING SOUND WAS HEARD, PT COUGHED AND EXPERIENCED UNPLANNED EXTUBATED. PT WAS REINTUBATED WITHOUT PROBLEMS AND NEW E.T. TAPE-II DEVICE WAS APPLIED. E.T. TUBE-II WAS REPORTED TO HAVE SEPARATED AT THE POSITION WHERE ENDOTRACHEAL TUBE WAS ATTACHED. NO FURTHER INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E.T. TAPE-II DEVICE FIXATION TRACHEAL TUBE 868-5770 CBH B & B MEDICAL TECHNOLOGIES, INC. 11010 D820616

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening| O NOT REPORTED