BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXICOUPLER DISPOSABLE EAR PHONES

    MDR report key: 6945368 · Received October 12, 2017

    Report

    Report Number
    3018859-2017-00773
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    August 17, 2017
    Report Date
    September 12, 2017
    Manufacturer
    NATUS MEDICAL INC.
    Product Code
    GWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THE ROOT CAUSE WAS INITIATED IN ACCORDANCE WITH THE NATUS CORRECTIVE AND PREVENTIVE ACTION PROCESS. A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO KATECHO, INC., THE SUPPLIER OF THE FLEXICOUPLERS INVOLVED IN THE COMPLAINT. 24 UNITS FROM THE SAME LOT OF FLEXICOUPLERS WERE RETURNED TO NATUS ON 10/4/2017, AND THE USER REPORTED THAT THEY HAD NO ADDITIONAL ITEMS OF THE SAME LOT NUMBER REMAINING. THE UNITS RETURNED WERE THEN FORWARDED TO KATECHO, INC.. THE SAMPLES WERE SUBJECTED TO A LINER PEEL TEST AND GEL-TO-GEL TEST BY THE SUPPLIER. THE LINER PEEL TEST RESULTS SHOWED THE AVERAGE OF THE 24 UNITS WAS WITHIN SPECIFICATION. SEVEN INDIVIDUAL LINER PEEL TESTS WERE FOUND TO BE ABOVE THE UPPER LIMIT, AND THE REMAINING UNITS WERE WITHIN SPECIFICATION. ALL OF THE GEL-TO-GEL TEST RESULTS WERE WITHIN THE SPECIFICATION LIMITS. ROOT CAUSE FOR THE INCREASE IN HYDROGEL ADHESION WAS THAT THE HYDROGEL ON THE FLEXICOUPLERS WERE SUBJECTED TO A DIFFERENT UV CURING PROFILE AS A RESULT OF THE USE OF A NEW/ALTERNATE PRODUCTION LINE. THIS RESULTED IN A WIDER RANGE OF VARIATION FOR ADHESION ACROSS THE LOT, I.E., ELEVATED ADHESION. THIS WAS OBSERVED IN THE FIELD AS AN INCREASE IN SKIN ADHESION. THE REDUCTION IN UV ENERGY OBSERVED ON THE UV PUCK READING RUN CHART DIRECTLY CORRESPONDS TO THE PRODUCTION OF THE COMPLAINT LOTS. ALTHOUGH THE REQUIRED MINIMUM CURE UV ENERGY WAS MAINTAINED, THE PROFILE BY WHICH THE HYDROGEL IS CURED IS DIFFERENT. THE NEW/ALTERNATE PRODUCTION LINE PASSES THE HYDROGEL/PRODUCT THROUGH A UV TUNNEL WITH 3 STOPS, WHILE THE HISTORICAL LINE UTILIZES 5 STOPS. THIS CAN BE OBSERVED ON THE UV PUCK RUN PROFILE THAT IS PERFORMED EACH DAY DURING THE PRODUCTION RUN. WHILE THE AMOUNT OF UV ENERGY OUTPUT CONTRIBUTES THE ADHESIVE PROPERTIES OF THE HYDROGEL, THE PROFILE AT WHICH THE ENERGY IS APPLIED IS THE MAIN FACTOR. IT WAS BELIEVED AT THE TIME OF USE OF THE NEW ALTERNATE LINE, THAT THE AMOUNT OF TIME OF UV CURE WITHIN THE UV TUNNEL MIMICKED THAT OF THE CURRENT/HISTORICAL LINE. IN ACCORDANCE WITH THE SUPPLIER CORRECTIVE ACTION REQUEST, THE SUPPLIER REPORTED THAT THEY WOULD NO LONGER BE USING THE NEW/ALTERNATE PRODUCTION LINE TO MANUFACTURE FLEXICOUPLERS. THE SUPPLIER REPORTED THAT THEY WOULD NOT RE-INSTITUTE THE NEW/ALTERNATE PRODUCTION LINE WITHOUT PRIOR APPROVAL FROM NATUS WHICH IS A REQUIREMENT OF THE SUPPLIER'S ECO PROCESS.

    Additional Manufacturer Narrative · 1

    PRODUCT FROM THE SAME LOT WAS RECEIVED BY NATUS AND SENT TO THE MANUFACTURER FOR ANALYSIS AND ROOT CAUSE EVALUATION. NATUS HAS ALSO INTIATED ROOT CAUSE ANALYSIS FOR CORRECTIVE ACTION EFFORTS, AND THIS INVESTIGATION IS ONGOING AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    NATUS MEDICAL RECEIVED MEDWATCH REPORT (B)(4) ON (B)(6) 2017. THE FIRST EVENT LISTED ON THE MEDWATCH REPORTS THAT WHILE BEING ADMINISTERED A HEARING TEST, A NEWBORN PATIENT HAD THE DISPOSABLE EARPHONES ADHERING TOO TIGHTLY TO THE SKIN AROUND THE PATIENT'S EARS. REDNESS WAS NOTED BY THE NURSES UPON REMOVING THE EARPHONES. NO TREATMENT OR MEDICAL INTERVENTION HAD TO BE ADMINISTERED AS A RESULT OF THIS EVENT. THE USER ALSO REPORTS THEY WERE ABLE TO TRACE THE MALFUNCTION TO A SPECIFIC LOT NUMBER. THERE HAS BEEN NO REPORT OF DEATH, SERIOUS INJURY OR DELAY IN PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724076 FLEXICOUPLER DISPOSABLE EAR PHONES FLEXICOUPLER DISPOSABLE EAR PHONES GWJ NATUS MEDICAL INC. 011445 N050917

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other ALGO 3I NEWBORN HEARING SCREENER