NATURA

Description of Event or Problem

THE NURSE PRACTITIONER REPORTED THAT THE BASE PLATE WAS VERY RIGID, COULD NOT BE MOLDED, AND APPEARED ALMOST WHITE IN COLOR. THE PRODUCT WAS USED ON PATIENT; HOWEVER, THE DURATION OF USE WAS UNKNOWN. NO PHOTO WAS AVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

MDR 9618003-2026-00358 / DEVICE 1 OF 3 E1: COMPLAINANT CITY: (B)(6) COMPLAINANT STATE/PROVINCE: (B)(6) COMPLAINANT COUNTRY: GERMANY NAME OF AFFILIATION: VIVISOL INTENSIVSERVICE BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: NO PHOTOGRAPH ASSOCIATED WITH THIS CASE WAS RECEIVED. NO RETURN SAMPLE HAS BEEN RECEIVED FOR THIS COMPLAINT. BATCH RECORD REVISION RESULTS: - ASSEMBLY PROCESS PERFORMED IN THE CONVEX 2 PC LINE: THE LOT: 1D02621, ORDER (B)(4), MATERIAL 1175761, WAS MANUFACTURED ON 20/APR/2021 IN THE CONVEX 2 PC MANUFACTURING LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 11/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. -SUB-ASSEMBLY PROCESS PERFORMED IN THE CONVEX 2 PC LINE: THE SUBASSEMBLY LOT: 1D02619, ORDER (B)(4), MATERIAL 1156498, WAS MANUFACTURED ON 19/APR/2021 IN THE CONVEX SUBASSEMBLY MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 11/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. - EXTRUSION, LAMINATION & CUTTING PROCESS PERFORMED IN THE ELC #6 LINE: THE SUBASSEMBLY LOT: 1D02660, ORDER (B)(4), MATERIAL 1216903, WAS MANUFACTURED ON 20/APR/2021 IN THE ELC #6 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 11/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. - MIXING PROCESS PERFORMED IN THE AMK MIXER LINE: THE SUBASSEMBLY LOT: 1D01338, ORDER (B)(4), MATERIAL 1002208, WAS MANUFACTURED ON 19/APR/2021 IN THE AMK MIXER LARGE #2 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 11/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 1C04437, ORDER (B)(4), MATERIAL 1002208, WAS MANUFACTURED ON 09/APR/2021 IN THE AMK MIXER LARGE #2 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 11/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. THE SUBASSEMBLY LOT: 1D01337, ORDER (B)(4), MATERIAL 1002208, WAS MANUFACTURED ON 20/APR/2021 IN THE AMK MIXER LARGE #2 MANUFACTURING LINE, WITH A TOTAL OF (B)(4) EACH (EA). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 11/FEB/2026, AND IT WAS CONFIRMED THAT THE APPLICABLE PROCEDURES WERE FOLLOWED, THE MATERIALS WERE CORRECT AS PER BILL OF MATERIALS (BOM), AND THE EQUIPMENT SETTINGS WERE ACCORDING TO THE PROCESS INSTRUCTION. 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 11/JAN/2025, THE COMPLAINTS ENGINEER RAN A QUERY IN DATABASE TO VERIFY THE COMPLAINTS REPORTED FOR THE LOT 1D02621 AND THE MALFUNCTION ¿SKIN BARRIER DOES NOT MOLD AROUND STOMA (E.G TOO STIFF, TOO DRY, TEARS /CRUMBLES WHEN MOLDING) AT POINT OF APPLICATION¿ AND AS RESULT ANY ADDITIONAL COMPLAINT WAS IDENTIFIED DURING THIS SEARCH AS PER WORK INSTRUCTIONS (WI). HISTORICAL NONCONFORMANCE REVIEW: ON 11/JAN/2025, THE COMPLAINTS ENGINEER RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION ¿SKIN BARRIER DOES NOT MOLD AROUND STOMA (E.G TOO STIFF, TOO DRY, TEARS /CRUMBLES WHEN MOLDING) AT POINT OF APPLICATION¿ FOR LOTS NUMBER 1D02621, 1D02619, 1D02660, 1C04437, AND 1D01337. AS A RESULT, NO NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) (S) FOR THIS MALFUNCTION WERE GENERATED DURING THE MANUFACTURING PROCESS OF THE REFERENCED LOTS. DEFECT RATE ANALYSIS: THERE HAVE BEEN 3 DEFECTIVE PARTS CONFIRMED TO DATE FROM A LOT SIZE OF (B)(4) PRODUCTS. THIS REPRESENTS A DEFECT RATE OF ONLY (B)(4), WHICH WAS WELL WITHIN AN APPROPRIATE ACCEPTABLE QUALITY LEVEL (AQL) FOR THIS DEFECT, WHICH SHOULD BE (B)(4) BASED ON OUR STANDARD OPERATING PROCEDURE (SOP). IN ADDITION, ALL OF THE IN-PROCESS TESTING ON THIS LOT DID NOT FIND A SINGLE DEFECTIVE POUCH, WHICH CONFIRMS THAT THE LOT WAS 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 WAS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSION: A BATCH RECORD REVIEW WAS CONDUCTED FOR THE FINAL PRODUCT LOT 1D02621, INCLUDING THE BULK LOTS (1D02619, 1D02660, 1C04437, AND 1D01337), CONFIRMING THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE WERE COMPLETED AND MET THE NECESSARY STANDARDS. NO DISCREPANCIES OR CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) (S) RELATED TO THIS ISSUE WERE IDENTIFIED IN THE DOCUMENTATION AND EQUIPMENT USED DURING TESTING WAS WITHIN CALIBRATION, ENSURING THE RELIABILITY OF THE RESULTS. ADDITIONALLY, A DEFECT RATE ANALYSIS WAS PERFORMED, AND THE AFFECTED QUANTITY FALLS WITHIN THE ACCEPTABLE AQL FOR THIS TYPE OF DEFECT. NO CHANGES TO THE END-TO-END MANUFACTURING PROCESS OR COMPONENTS USED DURING ASSEMBLY OF THE BATCH WERE PERFORMED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, STANDARD OPERATING PROCEDURE (SOP). 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.