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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: WHAT IS THE LOT NUMBER? UNK. A PHOTO UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PHOTO EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

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 SUCTIONING THE PANCREATIC JUICE AND 16 DAYS PASSED, IT WAS FOUND THAT THERE WAS A BLACK FOREIGN MATTER ATTACHED ON THE STANDARD TYPE OF SUCTION RESERVOIR. THE PANCREATIC JUICE WAS DISCARDED PER 150 ML TWO TO THREE TIMES A DAY. AFTER FINDING THE BLACK FOREIGN MATTER, THE USE WAS STOPPED. THE NURSE WOULD LIKE TO KNOW WHETHER THIS ISSUE IS CAUSED BY THE USAGE OR DEFECT, WHEN THE POSSIBILITY OF RUST OCCURS AFTER HOW MANY DAYS OF USING THE PRODUCT, AND THE APPROPRIATE PERIOD OF USAGE CYCLE. IT WAS USED AS THE PANCREATIC DUCT TUBE. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

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. H6 INVESTIGATION FINDINGS: C22 - PHOTO REVIEW. ADDITIONAL H3 INVESTIGATION SUMMARY: CUSTOMER PROVIDED A PICTURE FOR EVALUATION. THE BLACK FOREIGN MATTER THAT IS APPRECIATED IN THE PICTURE PROVIDED COULD NOT BE ATTRIBUTED TO MANUFACTURING PROCESS. IT SEEMS THAT IT IS PART OF THE DETRIMENTAL FLUIDS FROM THE PATIENT. IT IS NOT A MANUFACTURING DEFECT. BASED ON THE PRESENT ANALYSIS, AND CONDITION OF SAMPLE RECEIVED IT IS DETERMINED THAT THE REPORTED COMPLAINT IS NOT CONFIRMED TO BE 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 MANUFACTURER CONTROL. CUSTOMER DID NOT PROVIDE LOT INFORMATION. THEREFORE, DHR REVIEW IS NOT APPLICABLE FOR THIS COMPLAINT INVESTIGATION.