BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 3030971 · Received March 28, 2013

    Report

    Report Number
    9611710-2013-00234
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    November 30, 2012
    Report Date
    March 5, 2013
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON AVAILABLE INFO, OUR MEDICAL DETERMINATION IS THAT A RECURRENCE OF THIS MALFUNCTION IS LIKELY TO CONTRIBUTE TO OR LEAD TO A SERIOUS INJURY/ILLNESS TO THE PT SERIOUS: A KINKED ENDOTRACHEAL TUBE WOULD NOT ALLOW SUFFICIENT VENTILATION OF A PT LEADING TO OXYGEN DE-SATURATION. A BRONCHOSCOPE OR A SUCTION CATHETER MAY ALSO BECOME 'STUCK' IN SUCH AN ETT CAUSING RESPIRATORY DISTRESS AND/OR ALVEOLAR COLLAPSE. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: "COMPLAINT DESCRIPTION: OWNING TO THE KINKING PROBLEM IT FAILED TO SUCTION DURING THE PROCEDURE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128600 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TUBE, TRACHEAL BTR UNOMEDICAL SDN BHD MM61110075 610634R002

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening