J-VAC*RESV. 150 ML

Description of Event or Problem

IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN BREAST AND ENDOCRINE SURGERY ON (B)(6) 2025 AND A RESERVOIR WAS USED. WHEN PLACING THE DRAIN, THE RESERVOIR OPENED BY ITSELF. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DID THE ISSUE OCCUR DURING ACTIVATION? UNK. WAS THE PRODUCT USED ON THE PATIENT? UNK. PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN NOTES OR RMAO SECTIONS. THE DEVICE HAS BEEN RECEIVED AT SUKAGAWA AND WILL BE SHIPPED. PLEASE CHECK RMAO. PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP OR LOC/BQ) (B)(6). 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. ADDITIONAL INFORMATION: D9, H3, H4, H6. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL H3 INVESTIGATION SUMMARY: MAN. TIE TOO LONG. DURING SAMPLE EVALUATION THE PLATE WAS ABLE TO BE OPEN AND CLOSE WITHOUT ANY ISSUE. THE STRAP DID NOT INTERFERE ON THE CORRECT FUNCTION OF THE LOCKING MECHANISM. THEREFORE, IS CONSIDERED THIS MAN FACTOR DOES NOT CONTRIBUTE TO THE REPORTED COMPLAINT DEFECT. MATERIALS 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 WERE IN GOOD CONDITIONS; THE PLATE WAS ABLE TO BE OPEN AND CLOSE. 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. 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 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 MANUFACTURER CONTROL.