J-VAC*RESV. 150 ML

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT? 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 OPEN BREAST SURGERY ON AN UNKNOWN DATE AND A RESERVOIR USED. AT WARDS/ICU, THE DISCHARGE PORT OF RESERVOIR WAS LOOSE. 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). 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 INFORMATION: D9, H3, H6. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. INVESTIGATION SUMMARY MACHINE WELDING ISSUES IN THE PORTS. WELDING AROUND THE PORTS WAS INSPECTED AND IT WAS FOUND IN GOOD CONDITION. IT WAS REVIEWED IF THERE WAS MELTING ON THE EXIT PORT THAT COULD AFFECT ITS DIAMETER BUT EXIT PORT AND ENTRANCE PORT WERE IN GOOD CONDITION. UNEVEN/INCOMPLETE PORT TRIM. EXIT AND INLET TUBES WERE VERIFIED ON SAMPLE RECEIVED, TUBES WAS COMPARED WITH OTHER SAMPLES AND HAD THE CORRECT LENGTH, IN ADDITION DURING MANUFACTURING PROCESS TUBES ARE CUT USING A FIXED FIXTURE TO PROVIDE THE APPROPRIATE DIMENSION. THE EXIT AND INLET PORTS OF SAMPLE PROVIDED FOR EVALUATION WERE ALSO VISUALLY VERIFIED, IT COULD BE OBSERVED THE CUT OF THE TUBES WERE EVEN (STRAIGHT) AND THE PLUGS FIT CORRECTLY INTO THE TUBES. THEREFORE, IS CONSIDERED THESE MACHINE FACTORS DO NOT CONTRIBUTE TO THE REPORTED COMPLAINT DEFECT. MATERIAL EXIT PORT PLUG OUT OF SPEC. INCOMING INSPECTION RECORDS FOR THE TUBES USED IN THE EXIT PORT OF LOTS OF THE REPORTED COMPLAINT WERE REVIEWED AND NO ISSUE WERE RECORDED, ALL CHARACTERISTICS EVALUATED PASS THE ACCEPTANCE CRITERIA. THEREFORE, IS CONSIDERED THIS MATERIAL FACTOR DOES NOT CONTRIBUTE TO THE REPORTED COMPLAINT DEFECT. MAN INADEQUATE USAGE OF DEVICE. IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU) FOR THIS MEDICAL DEVICE, THIS IS A SUCTION RESERVOIR, AND IT IS DESIGNED TO EVACUATE POTENTIALLY DETRIMENTAL COLLECTION OF CERTAIN FLUIDS FROM WOUNDS IN BODY CAVITIES THOUGH ITS MECHANISM OF SUCTION. THEREFORE, IN ORDER TO HAVE A PROPER FUNCTIONALLY AND FOR THE CORRECT ACTIVATION OF THIS SUCTION RESERVOIR IT IS NECESSARY THAT AFTER DRAIN TUBING IS CONNECTED TO THE PORT, START THE SUCTION BY GENTLY BENDING UP THE BOTTOM FLAP, THE UNIT WILL RELEASE, AND SUCTION WILL BEGIN, IN ADDITION, AN AIRTIGHT SEAL BETWEEN ALL SYSTEM COMPONENTS (DRAIN, ADAPTER, AND RESERVOIR) IS NECESSARY FOR PROPER SYSTEM FUNCTION. TO DEVIATE THE GIVEN INDICATIONS IS CONSIDERED AN INADEQUATE USAGE OF THIS SUCTION RESERVOIR. THEREFORE, IT IS CONSIDERED THIS MAN FACTOR COULD CONTRIBUTE TO THE REPORTED COMPLAINT DEFECT. 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.