BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 17496522 · Received August 10, 2023

    Report

    Report Number
    9618003-2023-00783
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Report Date
    July 13, 2023
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    UDI-DI
    00768455187041
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS H10: INVESTIGATION SUMMARY PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE ARE PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND IN THESE, THE REPORTED DEFECT CAN BE SEEN. NO UNUSED RETURN SAMPLE WAS EXPECTED. BATCH RECORD REVISION RESULTS: LOT 2K00982 WAS MANUFACTURED ON 10/08/2022, IN ATS #2 LINE, WITH A TOTAL OF (B)(4) MKUS. THE COMPLIANCE ENGINEER PERFORMED A BATCH RECORD REVIEW ON 13/OCT/2023, 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, SYSTEM APPLICATION PRODUCT (SAP) MATERIAL ID 1222278 AND MANUFACTURING ORDER (B)(4). THE PRODUCTION PROCESS, IN-PROCESS CONTROL, TESTING RESULTS AND PACKAGING OF PRODUCTS WAS RUN ACCORDING TO THE PROCESS INSTRUCTION AND RECORDED IN BR31-144 VER. 5.0. REVIEW OF THE BATCH RECORD SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. HISTORICAL COMPLAINTS REVIEW: ON 13/OCT/2023, COMPLIANCE ENGINEER RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 2K00982 LOT FOR THE MALFUNCTION CODE ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (MOLDABLE ONLY)¿ AND AS RESULT, NO ADDITIONAL TYPE 2 COMPLAINTS WERE IDENTIFIED DURING THIS SEARCH. HISTORICAL NONCONFORMANCE REVIEW: ON 13/OCT/2023, COMPLIANCE ENGINEER RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE ACTION / PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION CODE ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (MOLDABLE ONLY)¿FOR THE LOT NUMBER 2K00982 AND AS RESULT, NO NONCONFORMANCE / CAPA (S) FOR THIS MALFUNCTION CODE WERE GENERATED DURING THE MANUFACTURING PROCESS OF THE REFERENCED LOT. CURRENT QUALITY CONTROLS: BASED ON THE PROCESS INSTRUCTION, THE FOLLOWING TESTS ARE PERFORMED IN THE MANUFACTURING LINES, IN ORDER TO IDENTIFY THIS FAILURE MODE IN OUR MANUFACTURING PROCESS: PROCESS INSTRUCTION (PI) ¿ADHESIVE DISC ALIGNMENT¿: ¿ FREQUENCY: CONTINUOUS VISUAL INSPECTION ¿ SAMPLE QUANTITY: ALL MANUFACTURED UNITS ¿ ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1 PI31-144 SEC 8.1 PROCESS INSTRUCTION (PI) ¿COLLAR CONCENTRICITY¿: ¿ FREQUENCY: 48 SAMPLES PER SHIFT (6 SAMPLES PER HOUR) ¿ SAMPLE QUANTITY: 6 SAMPLES PER HOUR ¿ ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1 DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN 1 DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE OF 152900 PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY 0.001%, WHICH IS WELL WITHIN AN APPROPRIATE AQL FOR THIS DEFECT WHICH SHOULD BE 0.25% BASED ON OUR (B)(4) VER. 24.0. IN ADDITION, ALL OF THE IN-PROCESS TESTING ON THIS LOT DID NOT FIND A SINGLE DEFECTIVE POUCH, WHICH CONFIRMS THAT THE LOT IS UNLIKELY TO BREACH AN AQL OF 0.25. THIS ISSUE CERTAINLY APPEARS TO BE AN ISOLATED INCIDENT, BUT MORE IMPORTANTLY TO DATE, IT IS WELL WITHIN OUR ACCEPTED AQL LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSIONS: THE REVIEW OF THE BATCH RECORD FOR LOT 2K00982 SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS, ALL APPLICABLE MANUFACTURING AND QUALITY PROCESSES WERE FOLLOWED, AND NO DISCREPANCIES OR DEVIATIONS WERE RECORDED. NO CHANGES TO THE END-TO-END MANUFACTURING PROCESS OR COMPONENTS USED DURING ASSEMBLY OF THE BATCH WERE MADE. NO NONCONFORMITY HAS BEEN REGISTERED DURING THE MANUFACTURING PROCESS OF THE AFFECTED LOT FOR THE MALFUNCTION CODE ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (MOLDABLE ONLY)¿. NO ADDITIONAL COMPLAINTS WERE REPORTED FOR LOT AFFECTED RELATED TO THE MALFUNCTION CODE ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (MOLDABLE ONLY)¿. BASED ON THIS, NO NEGATIVE TREND WAS IDENTIFIED. 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

    Additional Manufacturer Narrative · 0

    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. 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

    Description of Event or Problem · 0

    THE END USER REPORTED THAT STARTER HOLE OF ONE WAFER WAS OFF CENTERED. THE PRODUCT WAS NOT USED BY PATIENT. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382621 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 411804 2K00982 00768455187041

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown