BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURA

    MDR report key: 16394411 · Received February 17, 2023

    Report

    Report Number
    9618003-2023-00225
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Report Date
    January 24, 2023
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    EXE
    UDI-DI
    00768455187034
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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. AN INVESTIGATION WAS COMPLETED FOR THIS COMPLAINT BY THE ASSIGNED MANUFACTURING SITE INVESTIGATION TEAM. THE COMPLAINT SUMMARY OF THIS INVESTIGATION REQUIRED REWORK. A CORRECTIVE ACTIONS/PREVENTIVE ACTIONS (CAPA) WAS RAISED AND AN UPDATED/CORRECTED INVESTIGATION SUMMARY HAS BEEN COMPLETED IN ACCORDANCE WITH ASSIGNED CAPA. A SUPPLEMENTAL MDR IS BEING SUBMITTED TO DOCUMENT THE COMPLETION OF INVESTIGATION REWORK AND FINAL INVESTIGATION; THE COMPLAINT RECORD WILL PROCEED TO CLOSURE. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: NO PHOTOGRAPHS ASSOCIATED WITH THIS CASE WERE RECEIVED AND NO UNUSED RETURN SAMPLE WAS EXPECTED. BATCH RECORD REVISION RESULTS: LOT 2G01539 WAS MANUFACTURED ON 7/16/2022, IN ATS #2 LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLIANCE ENGINEER PERFORMED A BATCH RECORD REVIEW ON 27/SEP/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 1222274 AND MANUFACTURING ORDER (B)(4) . THE PRODUCTION PROCESS, IN-PROCESS CONTROL, TESTING RESULTS AND PACKAGING OF PRODUCTS WAS RUN ACCORDING TO THE PROCESS INSTRUCTION (PI) 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 27/SEP/2023, COMPLIANCE ENGINEER RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR THE 2G01539 LOT FOR THE MALFUNCTION CODE ¿SKIN BARRIER DOES NOT MOLD AROUND STOMA (E.G TOO STIFF, TOO DRY, TEARS /CRUMBLES WHEN MOLDING) AT POINT OF APPLICATION¿ AND AS RESULT, NO ADDITIONAL TYPE 2 COMPLAINTS WERE IDENTIFIED DURING THIS SEARCH AS PER WORK INSTRUCTION. HISTORICAL NONCONFORMANCE REVIEW: ON 27/SEP/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 DOES NOT MOLD AROUND STOMA (E.G TOO STIFF, TOO DRY, TEARS /CRUMBLES WHEN MOLDING) AT POINT OF APPLICATION¿ FOR THE LOT NUMBER 2G01539 AND AS RESULT, NO NONCONFORMANCE / CORRECTIVE ACTION / PREVENTIVE ACTIONS (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: BR31-144 SECTION 3.0 ¿DIMENSIONAL VERIFICATION AND VISUAL INSPECTION¿: FREQUENCY: 24 TIMES PER SHIFT (3 PER HOUR). SAMPLE QUANTITY: 1 PIECE PER HEAD AND 3 PER HOUR. ACCEPTANCE CRITERIA: ACCEPT = 0 / REJECT = 1 . DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN 1 DEFECTIVE PART CONFIRMED TO DATE FROM A LOT SIZE OF 55200 PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY (B)(4) , WHICH IS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR THIS DEFECT WHICH SHOULD BE (B)(4) BASED ON OUR STANDARD OPERATING PROCEDURE (SOP) ¿QUALITY INSPECTION PLAN¿. 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 ACCEPTABLE QUALITY LEVEL (AQL) OF 0.25. THIS ISSUE CERTAINLY APPEARS TO BE AN ISOLATED INCIDENT, BUT MORE IMPORTANTLY TO DATE, IT IS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSIONS: NO OBJECTIVE EVIDENCE WAS RECEIVED SUCH AS A PHOTO OR SAMPLE, FOR THIS REASON, WE CANNOT CONCLUDE THAT THE PRODUCT DOES NOT MEET SPECIFICATIONS. THE REVIEW OF THE BATCH RECORD FOR LOT 2G01539 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 DOES NOT MOLD AROUND STOMA (E.G TOO STIFF, TOO DRY, TEARS /CRUMBLES WHEN MOLDING) AT POINT OF APPLICATION¿. NO ADDITIONAL COMPLAINTS WERE REPORTED FOR LOT AFFECTED RELATED TO THE MALFUNCTION CODE ¿SKIN BARRIER DOES NOT MOLD AROUND STOMA (E.G TOO STIFF, TOO DRY, TEARS /CRUMBLES WHEN MOLDING) AT POINT OF APPLICATION¿. BASED ON THIS, NO NEGATIVE TREND WAS IDENTIFIED. BASED ON PRELIMINARY INVESTIGATION RESULTS, THERE IS NO OBJECTIVE EVIDENCE THAT OTHER PRODUCTS FROM THIS LOT ARE IMPACTED, AND THE ISSUE APPEARS TO BE ISOLATED. 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

    (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. FDA REGISTRATION NUMBER; REPORTING SITE: (B)(4). MANUFACTURING SITE: (B)(4).

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED BY HEALTHCARE PROFESSIONAL NURSE THAT END USER¿S WIFE TRIED TO MOLD ONE MOLDABLE WAFER FROM MARKET UNIT WITH KNOWN LOT AND FELT THAT THE MASS WAS MORE RIGID AND DID NOT BEND TO THE END USER¿S ABDOMEN CAUSING THEM TO PRESS MORE TO MAKE IT CONFORM TO THE ABDOMEN. THE PRODUCT WAS NOT USED ON END USER. ALSO, SHE WAS UNCERTAIN OF THE STOMA SIZE BUT ESTIMATED IT AT THE SIZE OF A HALF DOLLAR. SHE EXAMINED THE MEASURING GUIDE AND FELT THE STOMA MEASURED BETWEEN 32-38MM WHEREAS THE STOMA SIZE RANGE OF WAFER WAS 22-32MM. SHE WILL MEASURE STOMA SIZE WITH THE NEXT CHANGE AND TRY A LARGER SIZE SINCE LARGER STOMA WOULD NEED A LARGER SIZE OF WAFER. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116053 NATURA PROTECTOR, OSTOMY EXE CONVATEC DOMINICAN REPUBLIC INC 411803 2G01539 00768455187034

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown