J-VAC*RESV. 150 ML

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION PROVIDED: -LOT NUMBER OF (B)(4): UNK => JU1291 -PRODUCT NAME OF (B)(4): 2229 => 2227 (LOT#: UNK) ·THIS EVENT WAS NOTICED BY A WARD NURSE. ·THERE WERE NO PARTICULAR PROBLEMS AFTER IT WAS REMOVED, AND THE HOSPITAL SAID THAT THERE WOULD BE NO PROBLEM IF IT WAS REPLACED WITH A NEW ONE. 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 RESERVOIR FUNCTION PROPERLY UPON FIRST ACTIVATION?=>UNK - IF YES, HOW LONG AFTER THE FIRST ACTIVATION HAPPENED DID THE ISSUE OCCURRED? - WAS ANOTHER RESERVOIR USED TO FULFILL NEED OF DRAINAGE?=>UNK - HOW WAS THE CASE COMPLETED?=>UNK - COULD YOU PLEASE CONFIRM THE DRAIN LOT NUMBER?=>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 AN UNKNOWN SURGERY ON AN UNKNOWN DATE A RESERVOIR WAS USED. AN UNKNOWN SURGERY, SUCTION FAILURE OCCURRED. IT IS POSSIBLE THAT THE BLACK SPOT WAS NOT PLACED DEEP ENOUGH, BUT THE CUSTOMER REQUESTED TO CHECK TO MAKE SURE THERE IS NO LEAKAGE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WERE NO PARTICULAR PROBLEMS AFTER IT WAS REMOVED, FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.