BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT

    MDR report key: 3901797 · Received May 8, 2014

    Report

    Report Number
    9611710-2014-00102
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 9, 2014
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT WAS REPORTED THAT THE DEVICE WAS NOT USED ON THE PATIENT. NO ADDITIONAL PATIENT/EVENT HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WIL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED IN PRE-TESTING THE CUFF INFLATION WAS INCOMPLETE OWNING TO THE CUFF ADHESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279961 ENDOTRACHEAL TUBES - AIRWAY MANAGEMENT TUBE, TRACHEAL (W/WO CONNECTOR) 73BTR BTR UNOMEDICAL SDN BHD MM61110070 614678R001

    Patients

    Seq Age Sex Outcome Treatment
    1