BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING

    MDR report key: 7763554 · Received August 8, 2018

    Report

    Report Number
    9618003-2018-00830
    Event Type
    Malfunction
    Date Received
    August 8, 2018
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS STATED IN THE BATCH RECORDS OF BULKING LOTS MANUFACTURED ON THE EXTRUDER LAMINATING 10 MACHINE, MATERIALS WERE USED AS INDICATED IN THE BILL OF MATERIAL (BOM), A LINE CLEARANCE WAS PERFORMED AT THE START OF MANUFACTURING OPERATION AND AT THE END OF THE PROCESS; FURTHERMORE, PERIODIC REVIEWS OF LINE CLEARANCE REQUIREMENTS ARE PERFORMED AT THE START-UP OF EACH SHIFT AND AFTER ELECTRICAL OR MAJOR MECHANICAL ADJUSTMENTS. ON MARCH 23, 2018, AN EXTRAORDINARY MAINTENANCE WAS PERFORMED TO THE EXTRUDER LAMINATING 10 MACHINE, WHILE RUNNING THE LOT NUMBER 8C04850 (ITEM NUMBER 1003413) BY THE MAINTENANCE AREA, RELATED TO ¿FAILURE IN THE COOLING TOWER¿. HOWEVER, THIS FAILURE DOES NOT IMPACT THE PROPERTIES OF THE PRODUCTS BASED ON QUALITY TESTING RESULTS. THE ADHESIVES TEST AND THE ¿STRIP TO STRIP T-PEEL WAS PERFORMED FOR THE FIRST PIECE OR AFTER MACHINE STOP WITH SATISFACTORY RESULTS. THE REQUIRED VISUAL INSPECTION TESTING WAS PERFORMED PER HOURS. DIMENSIONS AND PRODUCT CHARACTERISTICS TESTING WERE PERFORMED EVERY HALF HOUR; THE OVERALL THICKNESS WAS FOUND IN RANGE. ALL QUALITY AND MANUFACTURING TESTING WERE CONSIDERED ACCEPTABLE AND PROCESS PARAMETERS WERE PROPERLY SET AS DOCUMENTED. FINALLY, INSPECTIONS ARE PERFORMED BY QUALITY TO THE PACKAGED PRODUCT AND ALL RESULTS WERE SATISFACTORY. ON JANUARY 28, 2019, A QUERY WAS PERFORMED TO EACH INDIVIDUAL IMPACTED LOT (FINAL AND BULKING LOTS) IN THE SYSTEM TO CONFIRM IF ANY LOCAL EVENT, SUCH AS REWORK OR NONCONFORMANCE OCCURRED DURING THE MANUFACTURING PROCESS OF THOSE LOTS REGARDING TO THE SAME FAILURE MODE REPORTED. AS RESULT, NOT EVENTS WERE FOUND RELATED TO THIS FAILURE MODE. ON JANUARY 25, 2019, A QUERY WAS RUN FROM JANUARY 01, 2019 TO DECEMBER 31, 2018 TO COVER THE FULL YEAR IN THE SYSTEM LOOKING FOR CUSTOMERS REPORTING COMPLAINTS, ASSOCIATED TO THE REPORTED MALFUNCTION IN THE DOYEN A MACHINE. AS RESULT, A TOTAL OF SIX (06) COMPLAINTS WERE FOUND ASSOCIATED TO THE MENTIONED FAILURE MODE (INCLUDING THE ONES TRIGGERING THIS NONCONFORMANCE). NO NEGATIVE TREND IS OBSERVED, BASED ON THE TOTAL QUANTITY MANUFACTURED OF IMPACTED FINAL LOTS. NO SAMPLES WERE RECEIVED COULD BE MEASURED TO ANALYZE SAMPLES DIMENSIONS. BASED ON THE PICTURES PROVIDED BY CUSTOMERS, EVENTS REPORTED DOES NOT HAVE THE PROBABILITY OF HAPPENING DURING THE PACKING PROCESS. THE EXTRUDER LAMINATING PROCESS WAS EVALUATED THROUGH THIS INITIAL ASSESSMENT. BASED ON THE INITIAL ASSESSMENT PERFORMED THROUGH REVISION OF THE BATCH RECORDS DOCUMENTATION, PICTURES PROVIDED BY CUSTOMERS IN COMPLAINTS REPORTED AND PROCESS EVALUATION, THIS EVENT COULD NOT BE CONFIRMED DUE TO SAMPLES WERE NOT AVAILABLE TO MEASURE DRESSING DIMENSIONS, COULD NOT BE CONFIRMED IF PRODUCTS WERE USED DURING THE RECOMMENDED PERIOD AS ESTABLISHED IN THE INSTRUCTION FOR USE (MAXIMUM RECOMMENDED WEAR TIME IS UP TO SEVEN DAYS) FOR LOTS 8A01973. NO LOCAL EVENTS WERE FOUND RELATED TO MANUFACTURING REQUIREMENTS AS PER BATCH RECORDS REVIEW OF BULKING AND FINAL LOTS. HOWEVER, A DEFECT NOTIFICATION WAS GIVEN TO QUALITY AND MANUFACTURING ASSIGNED TO THE EXTRUDER LAMINATING 10 MACHINE TO MAKE THEM AWARE OF COMPLAINTS REPORTED BY CUSTOMERS. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, AS PER PROCEDURE. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTING SITE: (B)(4). MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: DRESSING, WOUND, OCCLUSIVE. (B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿THE DRESSING IS DIFFICULT TO REMOVE FROM PATIENTS' SKIN¿. THE COMPLAINANT WAS UNABLE TO PROVIDE THE QUANTITY OF PATIENTS OR AFFECTED PRODUCT. NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605175 DUODERM/GRANUFLEX/DUOACTIVE - MOISTURE RETENTIVE DUODERM CGF DRESSING NOT APPLICABLE NAD 187920 8A01973

    Patients

    Seq Age Sex Outcome Treatment
    1