BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 8678742 · Received June 7, 2019

    Report

    Report Number
    9618003-2019-04382
    Event Type
    Malfunction
    Date Received
    June 7, 2019
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: D4: UNIQUE IDENTIFIER (UDI) H6: INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS H10: INVESTIGATION SUMMARY BATCH RECORD REVIEW LOT 8G03493 WAS MANUFACTURED ON 08/01/2018 IN THE CONVEX 2PC LINE IN THE 29 BUILDING, WITH A TOTAL OF (B)(4) MARKET UNITS. COMPLAINT INVESTIGATOR PERFORMED A BATCH RECORD REVIEW ON 08/13/2019 TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BILL OF MATERIALS (BOM) AND ALL THE TOOLING INFORMATION DOCUMENTED WAS ALSO CORRECT, UNDER INTERNATIONAL COMMODITY CODE (ICC) 402207 SYSTEM APPLICATION PRODUCT (SAP) MATERIAL ID 1052422 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. RETURNED SAMPLE EVALUATION: PHOTOS RELATED TO THE REPORTED PROBLEM ARE AVAILABLE FOR EVALUATION. INVESTIGATION CONCLUSION: THE PURPOSE OF THIS INVESTIGATIONS WAS TO DETERMINE THE ROOT CAUSE ASSOCIATED INVESTIGATION WAFER DISC DECENTRALIZATION, COMPLAINT MALFUNCTION (SKIN BARRIER STARTER HOLE IS DEFECTIVE, E.G. MISALIGNMENT OR OFF CENTER, LEAKAGE MAY OCCUR), FOR LOTS MANUFACTURED IN CONVEX 2 PC BUILDING 8, HAINA, D.R. AFTER THE USE OF THE 6 M¿S METHODOLOGY TO DOCUMENT INVESTIGATION FINDINGS, EXPLORE AND ANALYZE PROBABLE CAUSES, IT WAS DETERMINED THE FOLLOWING ROOT CAUSES AND OPPORTUNITIES: 1. METHOD OPPORTUNITY: DUE TO THE FACT THAT THE OCCURRENCE OF THIS FAILURE MODE IS NOT CONSTANT, IT HAS PEAKS OF OCCURRENCE DURING THE PROCESS, IT IS OBSERVED THAT THE ACTUAL TESTING METHOD (RANDOM HOURLY SAMPLING) MAY NOT CAPTURED EFFECTIVELY THE DEFECTS PRIOR TO PACKAGING, SO IT IS SUGGESTED THE IMPLEMENTATION OF A CONTINUOUS TESTING METHOD TO ANTICIPATE TO ALL OF THE PEAKS. 2. MANPOWER OPPORTUNITY: A CERTIFICATION OF THE OPERATORS WHO HAVE DIRECT INFLUENCE DUE TO THE ¿FLANGE/WAFER LOADING¿ PROCESS IN THE OPERATION THEY ARE EXECUTING SHOULD BE CONSIDERED IN ORDER TO REDUCE THE LEARNING CURVE EFFECT IN PROCESS AND GUARANTEE THE TRAINING EFFECTIVENESS. THIS SHOULD BE PERFORMED IN CONJUNCT WITH THE QUALITY INSPECTOR, PROCESS ENGINEER OF SUCH LINE AND THE SUPERVISOR. 3. MACHINE: IT IS CONSIDERED THAT DUE TO THE OBSERVATIONS REGISTERED, MACHINERY IS THE ROOT CAUSE OF THIS INCIDENT. IT IS CONCLUDED THAT ALL THE MACHINERY/ TOOLING ITEMS COMPLIED WHEN COMPARED AGAINST DRAWING AND PROCESS INSTRUCTION (PI) PI21-139 REV 10.0 SPECIFICATIONS, HOWEVER DUE TO THE DEMANDS OF THE PROCESS, THESE TOOLING REQUIRE A DIMENSION MODIFICATION TO REDUCE THE VARIABILITY OF THE PROCESS. LISTED BELOW ARE THE OBSERVATIONS. ¿ MISALIGNMENT OF THE WAFER LOADING PINS. ¿ MISALIGNMENT OF THE UPPER WAFER LOADING PLATE. ¿ FIXATION OF THE UPPER WAFER LOADING PLATE AND LOWER WAFER LOADING PLATE. THE AUTOMATIC CONVEX 2 PC IN THE 29 BUILDING WAS ALSO EVALUATED FOR DECENTRALIZATION ISSUES, BUT DUE TO THE FACT THAT THE DESIGN AND FUNCTIONING OF THIS MACHINE IS DIFFERENT, THE ROOT CAUSE IDENTIFIED FOR THIS INVESTIGATION DO NOT APPLY TO THE AUTOMATIC CONVEX 2 PC BUILDING 29. THE DIFFERENCES RELY ON A DIFFERENT MECHANISM, INSTEAD OF A MANUAL LOADING STATION THE AUTOMATIC CONVEX 2 PC HAS A PICK N¿ PLACE MECHANISM TO HANDLE THE RAW MATERIAL THROUGH THE PRODUCTION. THERE IS NO MANUAL LOADING TOOLING IN THIS MACHINE, SO THE FAILURE MODE CONDITIONS NEEDED TO REPLICATE IT COULDN¿T BE MET. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED AND THIS COMPLAINT WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER REPORTING SITE: 1049092 MANUFACTURING SITE: 9618003.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (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 THE CENTER IS MISALIGNED ON THE BASEPLATE OF 40 WAFERS MAKING THEM UNFIT TO USE. PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474461 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 402207 8G03493

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown