BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOMETER ¿SAFETI¿PLUS WITH LUER SAMPLE PORT

    MDR report key: 6055584 · Received October 25, 2016

    Report

    Report Number
    3007966929-2016-00098
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Report Date
    October 7, 2016
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    FFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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. REPORTED TO THE FDA ON OCTOBER 25, 2016. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: MODEL # HAS BEEN CORRECTED FROM THE PREVIOUSLY SUBMITTED INITIAL MFR REPORT# 3007966929-2016-00098, REPORTED TO THE FDA ON OCTOBER 25, 2016. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON NOVEMBER 03, 2016.

    Description of Event or Problem · 1

    COMPLAINT FROM A NURSE REPORTING A NON-RETURN VALVE (NRV) FAULT AFTER ONE HOUR OF USE. REPORTER STATED "THE PRODUCT DID NOT ALLOW DRAINAGE OF URINE." THE PATIENT WAS CONNECTED TO THE DEVICE AND WAS GIVEN LASIX. URINE FLOW WAS APPARENT ABOVE NRV BUT NOT BELOW. A DOPPLER PERFORMED ON BLADDER SHOWED APPROXIMATELY 200ML OF FLUID IN BLADDER. DEVICE WAS DISCONNECTED FROM CATHETER AND PASSED THE INNER TUBE OF A PEN THROUGH THE PROXIMAL END OF DEVICE TUBING TO OPEN NRV AND THEN FLUSHED CATHETER TO ENSURE NO BLOCKAGE. RECONNECTED CATHETER TO THE DEVICE BUT STILL NO FLOW. REMOVED DEVICE AND CHANGED TO A SIMPLE DRAINAGE BAG AND URINE FLOWED. APPROXIMATE MEASUREMENT OF URINE IN BAG WAS 300 ML. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705757 UNOMETER ¿SAFETI¿PLUS WITH LUER SAMPLE PORT DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE FFG UNOMEDICAL LTD. 15810050190

    Patients

    Seq Age Sex Outcome Treatment
    1