BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 8065858 · Received November 13, 2018

    Report

    Report Number
    9618003-2018-03271
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    UDI-DI
    00768455126668
    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 RESULTS: A BATCH RECORD REVIEW WAS CARRIED OUT ON 22/NOV/2018 BY COMPLAINT INVESTIGATOR FOR THE AFFECTED LOT NUMBER 8A03532. THE AFFECTED LOT WAS MANUFACTURED FOLLOWING THE APPLICABLE PROCEDURES, ALL THE TEST PERFORMED COMPLY WITH THE APPLICABLE REQUIREMENTS, THE LINE CLEARANCE WAS EXECUTED PER STANDARD OPERATING PROCEDURE (SOP), THE RESULTS WERE DOCUMENTED, AND NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE MATERIAL COMPLIES WITH THE BILL OF MATERIALS (BOM), PROCEDURE INSTRUCTION (PI), PL, DS, TEST METHODS (TM), MT AND THE RESULTS ARE SATISFACTORY; NO NONCONFORMITY WAS FOUND IN THE PROCESS. SAMPLE/PHOTOS EVALUATION RESULTS: PHOTO WAS RECEIVED FOR EVALUATION. INVESTIGATION CONCLUSION: THE PURPOSE OF THIS INVESTIGATIONS WAS TO DETERMINE THE ROOT CAUSE ASSOCIATED INVESTIGATION WAFER DISC DECENTRALIZATION, COMPLAINT MALFUNCTION CODE SKIN BARRIER STARTER HOLE IS DEFECTIVE, E.G. MISALIGNMENT OR OFF CENTER, LEAKAGE MAY OCCUR, FOR LOTS MANUFACTURED IN CONVEX 2-PIECE (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 PROCEDURE INSTRUCTION (PI), 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. ACTIONS WILL BE TAKEN FOR EACH FACTOR AND ARE GOING TO BE SUMMARIZED ON CORRECTIVE AND PREVENTIVE ACTIONS (CAPA)PLAN. ACTIONS COVERED IN THIS INVESTIGATION WILL BE IMPLEMENTED IN CONVEX 2-PIECE (PC) BUILDING 8 INSIDE CONVATEC D.R., EXCEPT FOR AUTOMATIC CONVEX 2 PC, BECAUSE THE DESIGN AND FUNCTIONING OF THIS MACHINE IS DIFFERENT. THE INVESTIGATION 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 THAT THE "PRODUCT HAS OFF CENTER HOLE." NO HARM REPORTED, AS THE PRODUCT WAS NOT USED BY OR ON THE PATIENT. PHOTOS DEPICTING THE REPORTED COMPLAINT ISSUE WERE PROVIDED BY THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903607 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 404592 8A03532 00768455126668

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown