BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE- AIRWAY MANAGMENT

    MDR report key: 2920579 · Received December 27, 2012

    Report

    Report Number
    9611710-2012-00013
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 26, 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
    TW
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: THE LEAKAGE OF THE CUFF WAS NOTED IN USE. NO HARM OR INJURY TO PATIENT. BASED ON AVAILABLE INFO, MEDICAL DETERMINATION IS THAT THIS IS A SERIOUS MALFUNCTION. A LEAKING/RUPTURED ENDOTRACHEAL/TRACHEOSTOMY TUBE CUFF EXPOSES THE PATIENT TO THE RISK OF ASPIRATION OF GASTRIC CONTENTS AND A REDUCTION IN VENTILATION PRESSURE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTRACHEAL TUBE- AIRWAY MANAGMENT TUBE, TRACHEAL BTR UNOMEDICAL SDN BHD MM61110075 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening