BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E HVLP MUR ICU KCC 8.0MM

    MDR report key: 5890751 · Received August 19, 2016

    Report

    Report Number
    9611710-2016-00105
    Event Type
    Malfunction
    Date Received
    August 19, 2016
    Date of Event
    June 16, 2016
    Report Date
    July 29, 2016
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K050803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE KINKED WHILE IN USE FOR A PATIENT THAT WAS VENTILATOR-DEPENDENT BETWEEN (B)(6) 2016. ON (B)(6) 2016 PRESSURE CHANGES WERE NOTED WITH THE PATIENT, BOTH THE SUCTION CATHETER AND SCOPE WOULD NOT THREAD DOWN THE DEVICE. A KINK APPEARED TO BE IN THE MIDDLE OF THE SHAFT OF THE TUBE BETWEEN THE PILOT LINE. THE PATIENT WAS EXTUBATED AND RE-INTUBATED WITH A NEW DEVICE OF THE SAME TYPE AND SIZE. ALTHOUGH NO PATIENT HARM WAS REPORTED DUE TO THIS DEVICE MALFUNCTION, THE PATIENT EXPIRED SEVERAL WEEKS LATER DUE TO OTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540692 E HVLP MUR ICU KCC 8.0MM TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 35216

    Patients

    Seq Age Sex Outcome Treatment
    1