J-VAC RESERVIOR BULB 100 CC

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. ADDITIONAL INFORMATION: D9, H3, H6. ADDITIONAL H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM . ADDITIONAL H3 INVESTIGATION SUMMARY: DOCUMENTS REVIEW : NOT APPLICABLE, AS LOT NUMBER OF THE COMPLAINT WAS UNKNOWN, HENCE, BATCH HISTORY REVIEW WAS NOT PERFORMED. RETENTION SAMPLE REVIEW : NOT APPLICABLE, AS LOT NUMBER OF THE COMPLAINT WAS UNKNOWN, HENCE, RETENTION SAMPLE REVIEW WAS NOT PERFORMED. REVIEW OF DEFECTIVE SAMPLE'S IMAGE / VIDEO : NOT APPLICABLE, AS THERE WAS NO COMPLAINT SAMPLE IMAGE / VIDEO RECEIVED FOR EVALUATION. COMPLAINT SAMPLE REVIEW : ONE COMPLAINT SAMPLE OF RESERVOIR BULB WAS RECEIVED FOR EVALUATION, PRODUCT WAS CHECKED VISUALLY AND FUNCTIONALLY; IN REFERENCE TO SUCTION ISSUE, NO NEGATIVE OBSERVATION WAS IDENTIFIED. AS PER STANDARD PRACTICE, 100% FUNCTIONAL TEST AND 100% VISUAL INSPECTION WAS CARRIED OUT, BEFORE AND AFTER PACKING OF FINISHED GOODS, PRIOR TO THE PRODUCT RELEASE. THERE WAS NO SCOPE TO MISS SUCH DEFECT, AT MANUFACTURING / RELEASE STAGE. DEVICE HISTORY REVIEW: AS LOT NUMBER OF THE COMPLAINT WAS UNKNOWN, HENCE, BATCH HISTORY REVIEW WAS NOT PERFORMED.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN EMERGENCY AND CRITICAL CARE PROCEDURE AT AN OUTPATIENT/TREATMENT ROOM ON (B)(6) 2025 AND A RESERVOIR WAS USED. DURING THE PROCEDURE, THE NEGATIVE PRESSURE COULD NOT BE APPLIED. 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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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.