J-VAC*RESV. 300 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 H6 TYPE OF INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHERE WAS THE TIP OF DRAINAGE TUBE LOCATED? UNK. HOW WAS THE DRAIN SECURED? UNK. WHAT WAS THE DATE OF FIRST ACTIVATION? UNK. HOW WAS THE PRODUCT FUNCTION VERIFIED FOLLOWING THE FIRST ACTIVATION? UNK. WHO MONITORED THE DRAINAGE AND HOW OFTEN? UNK. WAS BREAKAGE OF THE DRAIN NOTED? UNK. WERE THERE ANY PRECIPITATING FACTORS LEADING TO THE DRAIN LEAKAGE? UNK. PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE: UNK. THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? UNK. WERE ANY CONCOMITANT PROCEDURES PERFORMED? UNK. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? UNK. WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? UNK. WHAT IS THE PATIENT'S CURRENT STATUS? UNK. SURGEON¿S NAME? UNK.

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 FACTORS DO 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 SAMPLE 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. 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: REPLACING OF THE DRAIN WAS DONE AT THE WARD. WHAT IS THE LOT NUMBER OF THE J-VAC RESERVOIR INVOLVED? UNK WHAT IS THE LOT NUMBER OF THE BLAKE DRAIN INVOLVED? UNK PLEASE CLARIFY, FROM WHERE DID THE LEAKAGE COME FROM (BLAKE DRAIN OR J-VAC RESERVOIR) UNK WAS A NEW BLAKE DRAIN NEEDED TO COMPLETE THE CASE? OR JUST A J-VAC RESERVOIR? UNK, SALES REP SAYS THAT THE INCIDENT IS BEING CONFIRMED WITH THE HOSPITAL. PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN NOTES OR RMAO SECTIONS. WE REGULARLY CONTACT WITH SALE REP ABOUT THE DEVICE RETURNING. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHERE WAS THE TIP OF DRAINAGE TUBE LOCATED? HOW WAS THE DRAIN SECURED? WHAT WAS THE DATE OF FIRST ACTIVATION? HOW WAS THE PRODUCT FUNCTION VERIFIED FOLLOWING THE FIRST ACTIVATION? WHO MONITORED THE DRAINAGE AND HOW OFTEN? WAS BREAKAGE OF THE DRAIN NOTED? WERE THERE ANY PRECIPITATING FACTORS LEADING TO THE DRAIN LEAKAGE? PLEASE PROVIDE THE PATIENT'S DEMOGRAPHIC INFORMATION INCLUDING AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE THE DIAGNOSIS AND INDICATION FOR THE INDEX SURGICAL PROCEDURE? WERE ANY CONCOMITANT PROCEDURES PERFORMED? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS? WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT'S CURRENT STATUS? SURGEON¿S NAME? WILL PRODUCT BE RETURNED? IF SO, PLEASE PROVIDE THE RETURN DATE AND TRACKING INFORMATION.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN UROLOGICAL SURGERY ON (B)(6) 2025 AND A RESERVOIR WAS USED. DURING THE PROCEDURE AT THE WARD/ICU, AFTER USING THE PRODUCT IN THE ABDOMINAL CAVITY, DRAINAGE MANAGEMENT WAS CARRIED OUT IN THE WARD. AROUND NOON ON (B)(6) 2025, DRAINAGE LEAKAGE OCCURRED FROM THE ARMPIT, AND NEGATIVE PRESSURE COULD NOT BE APPLIED, SO THE NURSE CONTACTED THE DOCTOR, NEGATIVE PRESSURE WAS APPLIED AGAIN, AND THE PATIENT WAS MONITORED. IT IS UNCLEAR WHICH PART IS "THE ARMPIT" THAT THEY MEANT. AS THE CONDITION OF NOT APPLYING NEGATIVE PRESSURE CONTINUED, A REPLACEMENT PRODUCT WAS USED, AND DRAINAGE MANAGEMENT CONTINUED WITHOUT ANY PROBLEM. THE PRODUCT THAT DID NOT APPLY NEGATIVE PRESSURE WAS TREATED AS DEFECTIVE AND HANDED OVER TO THE DISTRIBUTION AGENCY. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.