BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 2945406 · Received February 1, 2013

    Report

    Report Number
    9611710-2013-00061
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    February 16, 2012
    Report Date
    February 16, 2012
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K080821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW ON PRIVATE LABEL COMPLAINTS FROM OUR FACILITY IN MALAYSIA. THIS IS RELATED TO (FDA AUDIT-OBSERVATION #7 FROM (B)(4)). BASED ON THE AVAILABLE INFORMATION THIS IS DEEMED TO BE A SERIOUS MALFUNCTION. THE ENDOTRACHEAL TUBE VENTILATOR ADAPTER DISCONNECTS EASILY FROM THE VENTILATOR. THIS COULD LEAD TO A SERIOUS ADVERSE EVENT. THE PATIENT WILL NOT BE ADEQUATELY OXYGENATED IF THE DELIVERY SYSTEM IS NOT FUNCTIONING AS INTENDED. RESPIRATORY DECOMPENSATION COULD PUT THE PATIENT AT RISK FOR HEMODYNAMIC INSTABILITY. ADDITIONALLY, THERE ARE RISKS INVOLVED IN EXTUBATING AND REINTUBATING (WITH A NEW DEVICE) A PATIENT WHO REQUIRE MECHANICAL VENTILATION AND IS NOT CAPABLE BREATHING ON THEIR OWN. REPORTED TO THE FDA ON (B)(6) 2013.

    Description of Event or Problem · 1

    THIS COMPLAINT IS BEING CREATED AS PART OF A FURTHER CORRECTION ACTION, RETROSPECTIVE REVIEW FOR 'PRIVATE LABEL' PRODUCT (FDA AUDIT-OBSERVATION #7). THE COMPLAINT WAS RECEIVED BY (B)(6) 2012, FROM KIMBERLY CLARK CORPORATION FOR PRODUCT ENDOTRACHEAL (PAEDIATRIC) TUBE SIZE 3.0MM. CUSTOMER COMPLAINING: "THE CONNECTOR OF THE GREEN ENDOTRACHEAL TUBE GOT DISCONNECTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45011 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TUBE, TRACHEAL BTR UNOMEDICAL SDN BHD 35111 607969R003

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening