FILTER RETENTION PLATE

Additional Manufacturer Narrative

THE DEVICE WAS AVAILABLE FOR INVESTIGATION. THE SURFACE OF THE HOUSING IS SLIGHTLY SCRATCHED, NO COMPONENT IS BROKEN ONLY DETACHED. AFTER REASSEMBLING THE COMPONENTS A FUNCTIONAL TEST WAS CARRIED OUT USING A CONTAINER LID FROM STOCK. THE TEST WAS SUCCESSFUL. THE FAILURE IST MOST PROBABLY USAGE RELATED. THE DETACHING OF THE HOUSING WAS MOST LIKELY CAUSED BY AN OVERLOAD SITUATION E.G. A DROP OF THE RETENTION PLATE DURING HANDLING. ACCORDING TO THE IFU ALL COMPONENTS NEED TO BE CHECKED BEFORE USE VISUALLY FOR DAMAGE AND CORRECT FUNCTION BEFORE EVERY USE. TO ENSURE A SAFE USAGE THE INSTRUCTIONS FOR USE MUST BE FOLLOWED UNDER ALL CIRCUMSTANCES.

Additional Manufacturer Narrative

GENERAL INFORMATION: WE RECEIVED A COMPLAINT ABOUT A MALFUNCTION OF A FILTER RETENTION PLATE. UP TO NOW, THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. CONSEQUENCES FOR THE PATIENT: ACCORDING TO THE AVAILABLE INFORMATION, THERE WERE NO NEGATIVE CONSEQUENCES FOR THE PATIENT. INVESTIGATION: UP TO NOW, THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. BATCH HISTORY REVIEW: THE TRACEABILITY OF ARTICLES WITHOUT BATCH MANAGEMENT REQUIREMENT IS GUARANTEED BY THE PRODUCTION ORDER NUMBER, WHICH CAN BE TRACED OVER THE PRODUCTION PERIOD AND THE CORRESPONDING CUSTOMER (BACKTRACK). IN ADDITION, THE RAW MATERIALS, SEMI-FINISHED PARTS, ETC. USED FOR THE ORDER ARE DOCUMENTED IN THE MANUFACTURING HISTORY RECORDS (DHR - DEVICE HISTORY RECORDS). THIS ENSURES THE TRACEABILITY OF THE INTERNAL SUPPLY AND PRODUCTION CHAIN. INTERNAL TRACEABILITY IS THUS GUARANTEED. CONCLUSION AND ROOT CAUSE: WITHOUT THE PRODUCT, AN EXACT CAUSE CANNOT BE DETERMINED AT THIS MOMENT. DUE TO THE CONSTANT MONITORING OF THE COMPLIANCE WITH OUR QUALITY STANDARDS, AS MATTERS STAND, A PRODUCTION OR MATERIAL DEFECT CAN MOST LIKELY BE EXCLUDED. THEREFORE, THE ROOT CAUSE OF THE ERROR IS MOST PROBABLY USAGE RELATED. FOR FURTHER INVESTIGATIONS, THE PRODUCT IS REQUIRED FOR EXAMINATION. RATIONALE: ACCORDING TO THE QUALITY STANDARD, A MATERIAL DEFECT AND PRODUCTION ERROR CAN BE EXCLUDED. A USAGE RELATED ERROR CANNOT BE EXCLUDED, E.G. DUE TO IMPROPER HANDLING OR AN OVERLOAD SITUATION. CHECK ALL COMPONENTS OF THE STERILE CONTAINER VISUALLY FOR DAMAGE AND CORRECT FUNCTION BEFORE EVERY USE. TO ENSURE A SAFE USE, INSTRUCTIONS FOR USE C48381 MUST BE FOLLOWED UNDER ALL CIRCUMSTANCES. CORRECTIVE ACTION: ACCORDING TO SOP SA-DE13-M-4-2-04-000-0 (CORRECTIVE ACTION AND PREVENTIVE ACTION), A CAPA IS NOT NECESSARY.

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH FILTER RETENTION PLATE. ACCORDING TO THE CUSTOMER DESCRIPTION: "RECURRENT DYSFUNCTION. BAD FIXATION OF THE FILTER WHICH DETACHED DURING STERILIZATION." THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER (B)(4).