BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 3202154 · Received June 28, 2013

    Report

    Report Number
    9611710-2013-00267
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PT HAS A NORMAL ANATOMY AND HE IS DOING WELL. NO COMPLICATIONS WERE REPORTED. BASED ON THE AVAILABLE INFORMATION, THIS ISSUE IS DEEMED A SERIOUS MALFUNCTION BECAUSE THE BRONCHOSCOPE OR SUCTION CATHETER BECAME 'STUCK' IN THE ENDOTRACHEAL TUBE AND POSSIBLY PUTTING THE PT AT THE RISK OF ALVEOLI COLLAPSE AND/OR OXYGEN DE-SATURATION. REPORTED TO THE FDA ON (B)(4) 2013. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE WE BECAME AWARE.

    Description of Event or Problem · 1

    THERE WAS PROBLEM WITH THE TUBE, THEY COULD NOT EXTUBATE/TAKE IT OUT. THE CUFF WAS STUCK TO THE TRACHEA. EVEN THE CUFF WAS DEFLATED. THE CUFF HAD CAUSED A HARD "BORDER" WHICH MADE A RESISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295054 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TRACHEOBRONCHIAL SUCTION CATHETER BSY UNOMEDICAL SDN BHD MM61114270 609004R001

    Patients

    Seq Age Sex Outcome Treatment
    1