J-VAC*RESV. 150 ML

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: D9 H3 EVALUATION: PRODUCT SAMPLE RECEIVED FOR ANALYSIS. MAN 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 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 SAMPLES 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.

Description of Event or Problem

IT WAS REPORTED A PATIENT UNDERWENT THE RESERVOIR HAD BEEN LOCKED HARD AND COULD NOT BE UNLOCKED. 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 PROVIDED: -LOT NUMBER OF (B)(4): UNK - JU1191. 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. "DID THE RESERVOIR FUNCTION PROPERLY UPON FIRST ACTIVATION? UNK. - IF YES, HOW LONG AFTER THE FIRST ACTIVATION HAPPENED DID THE ISSUE OCCURRED? UNK. - WAS ANOTHER RESERVOIR USED TO FULFILL NEED OF DRAINAGE? 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.