J-VAC*RESV. 300 ML

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). 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. WAS THE CONNECTION ISSUE NOTICED BEFORE ACTIVATING THE RESERVOIR? UNK. - DID THE RESERVOIR FUNCTION PROPERLY UPON FIRST ACTIVATION? UNK. - IF YES, HOW LONG AFTER THE FIRST ACTIVATION HAPPENED DID THE ISSUE OCCURRED? UNK. - PLEASE VERIFY IF THE CONNECTION WAS LOOSE BETWEEN THE ADAPTER AND RESERVOIR, OR THE DRAIN AND THE ADAPTER?=>UNK - IF NO, HOW MANY REACTIVATION WERE PERFORMED WHEN ISSUE WAS NOTICED? UNK. - WAS THE RESERVOIR USED WITH THE ADAPTER INCLUDED WITH THE CORRESPONDING BLAKE DRAIN? UNK. - COULD YOU KINDLY PERFORM AND DOCUMENT THE FOLLOW-UP ATTEMPT FOR THE PRODUCT RETURN? THE DEVICE WILL BE SHIPPED. - PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: (B)(6). 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.

Description of Event or Problem

IT WAS REPORTED A PATIENT UNDERWENT A TOTAL MASTECTOMY ON (B)(6) 2026 AND A RESERVOIR WAS USED. THE PRODUCT WAS USED AFTER THE COMPLETION OF THIS CASE. AN ABNORMALITY OCCURRED AT THE SUCTION PORT NEAR THE CONNECTION POINT. PRESSURE WAS RELEASED FROM THAT PART AND CAUSED LEAKAGE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. FURTHER DETAILS ARE NOT PROVIDED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WAS THE CONNECTION ISSUE NOTICED BEFORE ACTIVATING THE RESERVOIR? DID THE RESERVOIR FUNCTION PROPERLY UPON FIRST ACTIVATION? IF YES, HOW LONG AFTER THE FIRST ACTIVATION HAPPENED DID THE ISSUE OCCURRED? PLEASE VERIFY IF THE CONNECTION WAS LOOSE BETWEEN THE ADAPTER AND RESERVOIR, OR THE DRAIN AND THE ADAPTER? IF NO, HOW MANY REACTIVATION WERE PERFORMED WHEN ISSUE WAS NOTICED? WAS THE RESERVOIR USED WITH THE ADAPTER INCLUDED WITH THE CORRESPONDING BLAKE DRAIN? COULD YOU KINDLY PERFORM AND DOCUMENT THE FOLLOW-UP ATTEMPT FOR THE PRODUCT RETURN? FURTHERMORE, PLEASE ENSURE THAT THE SHIPMENT TRACKING NUMBER IS RECORDED IN THE NOTES OR RMAO SECTIONS. PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: 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.