BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT

    MDR report key: 5098057 · Received September 23, 2015

    Report

    Report Number
    9611710-2015-00161
    Event Type
    Malfunction
    Date Received
    September 23, 2015
    Date of Event
    July 26, 2015
    Report Date
    August 26, 2015
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. SINCE NO LOT NUMBER OR SAMPLE DEVICE HAVE BEEN RECEIVED, AN INVESTIGATION CANNOT BE PERFORMED AT THIS TIME. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER TWO WEEKS IN USE, THE ENDOTRACHEAL TUBE BECAME DEFORMED. THE COMPLAINANT FURTHER REPORTED THAT THE ENDOTRACHEAL WAS BENT "WITHOUT ANY CLINICAL OCCLUSION AND DID NOT ALTER THE AMOUNT OF OXYGEN DELIVERED TO THE PATIENT. DURING REMOVAL OF THE ENDOTRACHEAL TUBE, THE PATIENT "FELT UNCOMFORTABLE". THE DEVICE WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629641 ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD MM61110070 619607R003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown