J-VAC*RESV. 150 ML

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. ADDITIONAL H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM. ADDITIONAL H3 INVESTIGATION SUMMARY: MATERIAL: DAMAGED/ BROKEN COMPONENT: 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: INADEQUATE USAGE OF DEVICE: 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 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 ISSUES: 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: TEARS IN BAG. 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 THE 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 MANUFACTURE CONTROL.

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 INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: COULD YOU PLEASE PROVIDE THE LOT NUMBER? JU1085 DID THE J-VAC RESERVOIR COME IN CONTACT WITH SURGICAL INSTRUMENTS, SURGICAL NEEDLES, SUTURES, SHARP OBJECTS AT ANY TIME? UNK HOW WAS THE CASE COMPLETED? ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. WHEN THE PRODUCT WAS USED, THE RESERVOIR ITSELF HAD BEEN SWOLLEN, AND A HISSING SOUND WAS HEARD. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.