J-VAC*RESV. 150 ML

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN BREAST AND ENDOCRINE SURGERY ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. AT THE WARDS/ICU, THE NURSE NOTICED THAT THERE WAS DRAINAGE LEAKING FROM THE RESERVOIR. THERE WAS NO LEAKAGE FROM THE INSERTION SITE OR THE CONNECTION, SO THE LEAKAGE FROM THE RESERVOIR ITSELF WAS SUSPECTED, THEREFORE, USE WAS STOPPED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION: D9, H3, H6. INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, IT WAS REPORTED DURING AN UNKNOWN BREAST AND ENDOCRINE SURGERY AT THE WARDS/ICU, THE NURSE NOTICED THAT THE DRAINAGE LEAKING FROM THE RESERVOIR. THERE WAS NO LEAKAGE FROM THE INSERTION SITE OR THE CONNECTION, SO THE LEAKAGE FROM THE RESERVOIR ITSELF WAS SUSPECTED, SO THE USE WAS STOPPED. MATERIAL: DAMAGED / BROKEN COMPONENT. LOCKING MECHANISM OF RESERVOIR WAS CHECKED TO VERIFY ITS CONDITION. SAMPLE WAS EVALUATED, AND DURING THIS EVALUATION IT WAS NOTICE THAT THE LATCH OF PLATE AND ITS MECHANISM WAS IN GOOD CONDITION. IN ADDITION, PLATE SUBASSEMBLY NEEDS TO BE PROPERLY CLOSED IN ORDER TO PERFORM FINAL ASSEMBLY ON FINISH GOOD. THEREFORE, IS CONSIDERED THIS MATERIALS FACTOR DOES NOT CONTRIBUTE TO THE REPORTED COMPLAINT DEFECT. MACHINE. WELDING ISSUES. WELDING AROUND THE PORTS AND IN THE PERIMETER OF THE BAG WAS INSPECTED AND IT WAS IN GOOD CONDITION, THERE WAS NO PRESENCE OF WEAK WELDING OR OVER WELDING THAT COULD CAUSE A LEAKAGE. THE RESERVOIR WAS ACTIVATED WHILE THE CAPS WERE INSERTED ON THE PORTS EXPECTING THAT NO AIR WILL GO INTO THE RESERVOIR, THEN, THE BAG DID NOT INFLATE. IT MEANS THAT THERE IS NO DAMAGE ON THE FILM OF THE RESERVOIR. THEREFORE, IT IS CONSIDERED THAT MACHINE FACTOR DOES NOT CONTRIBUTE TO THE REPORTED COMPLAINT DEFECT. METHOD: TEARS IN BAG. RESERVOIR WAS INSPECTED AND IT WAS FOUND THAT THERE WAS A RUPTURE ON THE RIGHT SIDE OF THE BOTTOM AREA AS SHOWN IN PICTURE 3. THIS CONDITION IN THE BAG IS AFFECTING ITS FUNCTIONALLITY AND IT IS THE REASON OF LEAKAGE. THE SAMPLE SEEMS TO BE USED. CONDITION REPORTED BY CUSTOMER IS CONFIRMED. HOWEVER, IT IS DETERMINED THAT THIS CONDITION COULD NOT BE CAUSED BY FLEX MANUFACTURING PROCESS SINCE EVERY UNITS IS TESTED 100% FOR LEAK AND VISUALLY INSPECTED FOR ANY CONDITION THAT COULD AFFECT ITS PROPER FUNCTIONALITY. IN ADDITION AS PER QUALITY SAMPLING ROUTINES, ADDITIONAL TESTING IS PERFORMED IN ORDER TO ENSURE UNITS ARE IN COMPLIANCE TO CUSTOMER SPECIFICATIONS: -LEAK TEST. -COMPRESSION TETST. -VOLUME VS VACCUM TEST. -BURST TEST. -PULL TES. -PEEL TEST. BASED ON THE PRESENT ANALYSIS, AND CONDITION OF SAMPLE RECEIVED IT IS DETERMINED THAT THE REPORTED COMPLAINT IS CONFIRMED. HOWEVER, IT IS DETERMINED THAT THIS CONDITION COULD NOT BE CAUSED BY THE MANUFACTURING PROCESSS SINCE EVERY UNITS IS TESTED 100% FOR LEAK AND VISUALLY INSPECTED FOR ANY CONDITION THAT COULD AFFECT ITS PROPER FUNCTIONALITY. IN ADDITION AS PER QUALITY SAMPLING ROUTINES, ADDITIONAL TESTING IS PERFORMED IN ORDER TO ENSURE UNITS ARE IN COMPLIANCE TO CUSTOMER SPECIFICATIONS. OTHER EXTERNAL CAUSES COULD HAVE AFFECTED THE PRODUCT INTEGRITY SUCH AS HANDLING, NON-PROPER USAGE OR ANY OTHER POSSIBLE CONTRIBUTOR OUT OF THE FLEX CONTROL.