J-VAC*RESV. 150 ML

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: D9. H3 EVALUATION: PRODUCT SAMPLE RECEIVED FOR ANALYSIS. MATERIAL LOCKING MECHANISM OF RESERVOIRS WERE CHECKED TO VERIFY ITS CONDITION. SAMPLES WERE EVALUATED, AND DURING THIS EVALUATION IT WAS NOTICE THAT THE LATCH OF PLATE AND ITS MECHANISM WERE 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. MAN IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU) FOR THIS MEDICAL DEVICE, THIS IS A SUCTION RESERVOIR, AND IT IS DESIGNED TO EVACUATE POTENTIALLY DETRIMENTAL COLLECTION OF CERTAIN FLUIDS FROM WOUNDS IN BODY CAVITIES THOUGH ITS MECHANISM OF SUCTION. THEREFORE, IN ORDER TO HAVE A PROPER FUNCTIONALLY AND FOR THE CORRECT ACTIVATION OF THIS SUCTION RESERVOIR IT IS NECESSARY THAT AFTER DRAIN TUBING IS CONNECTED TO THE PORT, START THE SUCTION BY GENTLY BENDING UP THE BOTTOM FLAP, THE UNIT WILL RELEASE, AND SUCTION WILL BEGIN, IN ADDITION, AN AIRTIGHT SEAL BETWEEN ALL SYSTEM COMPONENTS (DRAIN, ADAPTER, AND RESERVOIR) IS NECESSARY FOR PROPER SYSTEM FUNCTION. TO DEVIATE THE GIVEN INDICATIONS IS CONSIDERED AN INADEQUATE USAGE OF THIS SUCTION RESERVOIR. THEREFORE, IT IS CONSIDERED THAT THIS MAN FACTOR COULD HAVE AFFECTED THE PRODUCT INTEGRITY AND ITS FUNCTION. MACHINE WELDING AROUND THE PORTS AND IN THE PERIMETER OF THE BAGS WERE 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 RESERVOIRS DIDN¿T PRESENT ANY DAMAGE OR TEARS ON THE FRONT OR THE BACK SIDE. PLATE WAS ACTIVATED, PORT CLOSED, AND THE SWELLED RESERVOIR WAS PRESSED TO VERIFY IF THERE COULD BE ANY VISIBLE LEAK. NO LEAK COULD BE IDENTIFIED. THEREFORE, IS CONSIDERED THIS METHOD FACTOR DOES NOT CONTRIBUTE TO THE REPORTED COMPLAINT DEFECT. BASED ON THE PRESENT ANALYSIS, AND CONDITION OF SAMPLES RECEIVED IT IS DETERMINED THAT THE REPORTED COMPLAINT IS NOT CONFIRMED AND IT IS NOT RELATED TO MANUFACTURING PROCESS AND OTHER EXTERNAL CAUSES COULD HAVE AFFECTED THE PRODUCT INTEGRITY SUCH AS HANDLING, NON-PROPER USAGE OR ANY OTHER POSSIBLE CONTRIBUTOR OUT OF THE MANUFACTURING CONTROL. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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 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.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND A RESERVOIR WAS USED. DURING THE PROCEDURE AT THE WARDS/ICU, NEGATIVE PRESSURE WAS TRIED TO APPLY, BUT THE RESERVOIR STARTED TO SWELL, AND NEGATIVE PRESSURE COULD NOT BE APPLIED. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.