BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 2920575 · Received December 27, 2012

    Report

    Report Number
    9611710-2012-00014
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 27, 2012
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS; ENDOTRACHEAL TUBE EASILY KINK, BLOCK AND IRREVERSIBLE BEND, EASILY CLOT BY SECRETION AND BLOCK THE TUBE. BASED ON AVAILABLE INFO, OUR MEDICAL DETERMINATION IS THAT THIS MALFUNCTION IS SERIOUS: IF THIS WERE TO REOCCUR DURING USE, A KINKED/TWISTED ENDOTRACHEAL TUBE CAN LEAD TO A COMPROMISE IN PATIENT VENTILATION SOMETIMES NECESSITATING AN EMERGENCY EXTUBATION AND REINTEGRATION. REPORTED TO THE FDA ON (B)(4) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TUBE, TRACHEAL BTR UNOMEDICAL SDN BHD MM61110070 608153R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening