BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 2961283 · Received February 8, 2013

    Report

    Report Number
    9611710-2013-00097
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K962389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2010. MORE INFO HAS BEEN REQUESTED ABOUT THIS SERIOUS ADVERSE EVENT. A PT SUFFERED RESPIRATORY DISTRESS DUE TO THE MALFUNCTION OF A TORN CUFF AROUND THE CONNECTOR OF AN ETT DURING THE PROCESS OF INTUBATION. CASE WILL BE UPDATED WHEN INFO IS RECEIVED. (B)(4) 2011. AFTER REPEATED REQUESTS, THERE HAS BEEN NO ADD'L INFO RECEIVED ON THIS CASE. IF NEW INFO IS FORTHCOMING, THE CASE WILL BE UPDATED. IT IS DEEMED TO BE A SERIOUS ADVERSE EVENT DUE TO THE RESPIRATORY DISTRESS EXPERIENCED WHEN THE CUFF TORE ON THE ETT. FROM A PRELIMINARY PERSPECTIVE, THE EVENT IS DEEMED POSSIBLY RELATED BECAUSE BLOOD OXYGEN LEVELS CAN DROP DUE TO THE INABILITY TO VENTILATE THE PT IF A CUFF ON AN ETT DEFLATES. NO INFO WAS PROVIDED ON THE FOLLOW-UP CONDITION OF THE PT. THE PRODUCT(S) IN THIS CASE IS/ARE NOT USED FOR TREATMENT OR DIAGNOSIS. (B)(4).

    Description of Event or Problem · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW OF COMPLAINTS FROM OUR FACILITY IN MALAYSIA. (B)(4). COMPLAINT RECEIVED AS FOLLOWS: "WHEN A NURSE INFLATED THE CUFF, INSIDE OF THE MAIN TUBE (AROUND CONNECTOR) WAS INFLATED AS WELL. IT IS SUPPOSED TO STAY INTACT. IT SEEMS SOMEWHERE AROUND THE CONNECTOR WAS TORN. IT ALMOST BLOCKED PT'S AIRWAY AND MADE IT VERY DIFFICULT FOR THE PT TO BREATHE. IT IS A VERY SERIOUS INCIDENT TO A PT AND TO US AS WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54353 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TUBE, TRACHAEL BTR UNOMEDICAL SDN BHD 61214075 699977/1

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening