ESTEEM+

Description of Event or Problem

TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11 (ADDL MFG NARRATIVE).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: DESCRIBE EVENT OR PROBLEM (B5): - PHOTOGRAPH DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT. H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS. H11: INVESTIGATION SUMMARY. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE WAS A PHOTOGRAPH ASSOCIATED WITH THIS CASE. NO RETURN SAMPLE HAS BEEN RECEIVED FOR THIS COMPLAINT. BATCH RECORD REVISION RESULTS: LOT 5B02812 WAS MANUFACTURED ON 14/FEB/2025, IN 23A LINE, WITH A TOTAL OF 648 MARKET UNITS (MKUS). THE COMPLAINT ENGINEER PERFORMED A BATCH RECORD REVIEW ON 28/JAN/2025, 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 IDENTIFICATION (ID) 1728761 AND MANUFACTURING ORDER (B)(4). 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 WAS FOUND WITHIN THE DOCUMENTATION. HISTORICAL COMPLAINTS REVIEW: ON 28/JAN/2025, COMPLAINT ENGINEER RAN A QUERY IN DATABASE IN ORDER TO VERIFY THE COMPLAINTS REPORTED FOR 5B02812 LOT FOR THE MALFUNCTION ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (PRE-CUT ONLY)¿ AND AS RESULT NO ADDITIONAL REPORTABLE COMPLAINTS WERE IDENTIFIED DURING THIS SEARCH AS PER WORK INSTRUCTIONS (WI). HISTORICAL NONCONFORMANCE REVIEW: ON 28/JAN/2025, COMPLAINT ENGINEER RAN A QUERY IN DATABASE LOOKING FOR ANY IN PROCESS NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) (S) ASSOCIATED TO THE MALFUNCTION ¿SKIN BARRIER STARTER HOLE IS DEFECTIVE (E.G MISALIGNMENT OR OFF CENTER), LEAKAGE MAY OCCUR (PRE-CUT ONLY)¿ FOR THE LOT NUMBER 5B02812 AND AS RESULT, NO NONCONFORMANCE / CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) (S) FOR THIS MALFUNCTION WERE GENERATED DURING THE MANUFACTURING PROCESS OF THE REFERENCED LOT. CURRENT QUALITY CONTROLS: BASED ON THE PROCESS INSTRUCTION (PI), THE FOLLOWING TESTS ARE PERFORMED IN THE MANUFACTURING LINES, IN ORDER TO IDENTIFY THIS FAILURE MODE IN OUR MANUFACTURING PROCESS: - VISUAL - ADHESIVE DISC TO FABRIC COLLAR CONCENTRICITY: THE ADHESIVE DISC SHOULD NOT TOUCH THE SRP ON THE FABRIC COLLAR. - TEST METHODS (TM) VISUAL NONCONFORMITIES OF THE POUCH. (B)(4). - DIMENSIONAL: LENGTH DIMENSIONS: STEEL RULER ANGLE DIMENSIONS: VISUAL WITH TEMPLATE. (B)(4). DEFECT RATE ANALYSIS: THERE HAVE ONLY BEEN SEVEN 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 LEAKAGE, WHICH SHOULD BE (B)(4) BASED ON OUR STANDARD OPERATING PROCEDURE (SOP). IN ADDITION, ALL THE IN-PROCESS TESTING ON THIS LOT DID NOT FIND A SINGLE DEFECTIVE UNIT, WHICH CONFIRMS THAT THE LOT WAS UNLIKELY TO BREACH AN ACCEPTABLE QUALITY LEVEL (AQL) OF (B)(4). THIS ISSUE CERTAINLY APPEARS TO BE AN ISOLATED INCIDENT, BUT MORE IMPORTANTLY TO DATE, IT WAS WELL WITHIN OUR ACCEPTED ACCEPTABLE QUALITY LEVEL (AQL) LEVEL FOR THIS TYPE OF FAILURE MODE OR DEFECT. CONCLUSIONS: A REVIEW OF BATCH RECORD WAS COMPLETED AND SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCIES RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. ADDITIONALLY, A REVIEW OF HISTORICAL COMPLAINTS WAS PERFORMED, AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED, AND A REVIEW OF HISTORICAL NONCONFORMANCES SHOWED NO ADDITIONAL NONCONFORMANCES. 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.

Additional Manufacturer Narrative

DEVICE 2 OF 7 E1: COMPLAINANT STATE/PROVINCE: (B)(6), COMPLAINANT COUNTRY: JAPAN. 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

THE END USER REPORTED WAFER WITH OFF CENTERED STARTER HOLE. THE PRODUCT WAS NOT USED. NO PHOTO IS AVAILABLE AT THIS TIME.