J-VAC*RESV. 450 ML

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION PROVIDED: THE DOCTOR COMMENTED THAT THIS DISCOLORING COULD BE THE REASON WHY THE CASES OF INCREASE THESE DAYS. 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 COME IN CONTACT WITH SURGICAL INSTRUMENTS, SURGICAL NEEDLES, SUTURES, SHARP OBJECTS AT ANY TIME? HOW WAS THE CASE COMPLETED? UNK. COULD YOU KINDLY PERFORM AND DOCUMENT THE FOLLOW-UP ATTEMPT FOR THE PRODUCT RETURN? THE DEVICE WILL BE SHIPPED. PLEASE CHECK RMAO. 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 PROCEDURE ON AN UNKNOWN DATE AND RESERVOIR WAS USED. RESERVOIR IS SWOLLEN. THE PRODUCT WAS NOT USED FOR THE PATIENT. 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: D9. H3 EVALUATION: SAMPLE WAS RETURNED FOR EVALUATION. MATERIAL REGARDING COMPONENTS DISCOLORATION/ CHANGE OF COLOR, THE COLOR SPECIFICATION APPLIES ONLY FOR MATERIAL BEFORE STERILIZATION PROCESS. IN RAW MATERIAL SPECIFICATION OF COMPONENTS (PLUGS, FILM, Y BODY), THE MATERIAL REQUIREMENTS SPECIFIED THAT COLOR MUST BE "TRANSLUCENT". NO ISSUES WERE FOUND FOR THE INVOLVED LOTS OF RAW MATERIAL, ACCORDING WITH INSPECTION REPORT PRODUCT MET SPECIFICATIONS ACCORDING TO APPLICABLE RMS. DURING MANUFACTURING PROCESS, THE COMPONENTS ARE INSPECTED FOR CONTAMINATION ACCORDING TO 034-FBA-MAP303, ACCORDING TO THE DEVICE HISTORY RECORD (DHR) NO NON-CONFORMANCES OR DEVIATIONS WERE ISSUED THAT COULD BE RELATED TO THE REPORTED COMPLAINT AND ALL PRODUCT INVOLVED WERE MANUFACTURE UNDER REQUIRED SPECIFICATION. THEREFORE, IS CONSIDERED THIS MATERIAL FACTOR DOES NOT CONTRIBUTE TO THE REPORTED COMPLAINT DEFECT. METHOD PRODUCT IS STERILIZED USING GAMMA RADIATION, IT KILLS BACTERIA BY BREAKING DOWN BACTERIAL DNA, INHIBITING BACTERIAL DIVISION. ENERGY OF GAMMA RAYS PASSES THROUGH THE EQUIPMENT, DISRUPTING THE PATHOGENS THAT CAUSE CONTAMINATION. LONIZING RADIATION CAN MODIFY PHYSICAL, CHEMICAL AND BIOLOGICAL PROPERTIES OF MATERIALS. THIS PROCESS MUST BE CONSIDERED A FACTOR FOR PRODUCT DISCOLORATION. ONE (1) SAMPLE WAS RETURNED FOR EVALUATION. SAMPLE EVALUATION WAS PERFORMED BASED ON COMPLAINT DESCRIPTION. 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). 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 COME IN CONTACT WITH SURGICAL INSTRUMENTS, SURGICAL NEEDLES, SUTURES, SHARP OBJECTS AT ANY TIME? UNK. HOW WAS THE CASE COMPLETED? 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). 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.