J-VAC RESERVIOR BULB 100 CC

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION PROVIDED: J-VAC RESERVIOR BULB 100 CC - 2160 (LOT: J2500420) (2160): LOT/LOT NUMBER: J2500420 LIST THE J&J PRODUCTS THAT WERE USED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. ## *** WAS THERE ANY HARM TO THE REPORTED PATIENT OR USER? ## NO *** WAS THERE A SIGNIFICANT DELAY? ## NO *** IF AVAILABLE, PLEASE PROVIDE THE PRODUCT ORDER NUMBER (PO). ## *** 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. WAS THE CONNECTION ISSUE NOTICED BEFORE ACTIVATING THE RESERVOIR? DID THE RESERVOIR FUNCTION PROPERLY UPON FIRST ACTIVATION? IF YES, HOW LONG AFTER THE FIRST ACTIVATION HAPPENED DID THE ISSUE OCCURRED? IF NO, HOW MANY REACTIVATION WERE PERFORMED WHEN ISSUE WAS NOTICED? WAS ANOTHER RESERVOIR USED TO CORRECT THE SITUATION? WAS THE RESERVOIR USED WITH THE ADAPTER INCLUDED WITH THE CORRESPONDING BLAKE DRAIN? COULD YOU KINDLY PERFORM THE FOLLOW-UP ATTEMPT FOR THE PRODUCT RETURN? PLEASE ENSURE THAT THE SHIPMENT TRACKING NUMBER IS PROVIDED. PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: H3 EVALUATION: NO PRODUCT WAS RECEIVED. RECEIVED PICTURES ARE CHECKED VISUALLY, (1): THE PHOTO SHOWS BROKEN CONNECTOR ON THE PORT ¿ THE TUBING CANNOT BE FIRMLY ATTACHED. (1): THE PHOTO SHOWS THE BULB DRAIN CONNECTOR PORT ONE SIDE IS BROKEN, SO THE TUBE CANNOT BE CONNECTED. (2): THE PHOTO SHOWS THE BULB DRAIN CONNECTOR PORT ONE SIDE IS BROKEN, SO THE TUBE CANNOT BE CONNECTED. CONCLUSION: BASED ON THE VISUAL REVIEW OF THE RECEIVED IMAGES, BULB DRAIN CONNECTOR PORT ONE SIDE IS BROKEN, SO THE TUBE CANNOT BE CONNECTED. 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. 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 IN 2026 AND A BULB RESERVOIR WAS USED. THE SUCTION RESERVOIR DID NOT HAVE THE LINE CONNECTOR THAT ALLOWS A SECURE ATTACHMENT OF THE DRAINAGE TUBE TO THE RESERVOIR BULB, SO IT WAS IMPOSSIBLE FOR THE CLINICIAN TO INSTALL THE RESERVOIR BULB SAFELY AND SECURELY ON THE PATIENT.