N
Patient 1
(B)(6). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. A BATCH RECORD REVIEW INDICATES NO DISCREPANCIES. MACHINE LOGS HAVE BEEN CHECKED AND NO DISCREPANCIES WERE FOUND. PREVENTIVE MAINTENANCE (PM) LOGS WERE CHECKED AND ALL PMS WERE COMPLETED WITH NO ISSUES FOUND. LOT # 8H03070 WAS STERILIZED UNDER LOT 1216022711 AND RELEASED ON REVIEW OF RESULTS OF STERILIZATION. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED IN COMPLIANCE WITH STANDARD OPERATING PROCEDURES. THE PRODUCTION PROCESS, IN PROCESS TESTING AND PACKAGING OF PRODUCTS WAS RUN IN ACCORDANCE WITH PROCESS INSTRUCTIONS FOR MACHINE DOYEN 3. VISUAL INSPECTION WAS PERFORMED IN ACCORDANCE WITH TEST METHODS AND WAS COMPLETED AT THE BEGINNING OF THE ORDER AND EVERY HOUR FOLLOWING UNTIL THE ORDER WAS COMPLETE. NO NONCONFORMITY WAS RAISED DURING THE MANUFACTURING PROCESS OF LOT 8H03070. THIS IS THE ONLY COMPLAINT FOR THE AFFECTED LOT REGISTERED WITHIN TW8.7. TWO (2) PHOTOGRAPHS HAVE BEEN RECEIVED FOR THIS ISSUE AND HAVE BEEN EVALUATED IN ACCORDANCE WITH WORK INSTRUCTIONS. THE PHOTOGRAPHS CONFIRM THE COMPLAINT ISSUE, THE LOT NUMBER AND THAT THIS IS THE PRODUCT EXPECTED. THE PHOTOGRAPHS SHOW DARK SPECKS ON THE DRESSINGS HOWEVER AS THE DRESSINGS ARE NO BEING RETURNED IT CANNOT BE CONFIRMED WHAT THE FOREIGN MATTER IS. OPERATORS WILL BE MADE AWARE OF THE COMPLAINT ISSUE. 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. (B)(4).