J-VAC

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. J-VAC RESERVOIR 450 ML (2162) : AFFECTED SIDE: DOES NOT APPLY ## REASON WHY THE PRODUCT IS NOT AVAILABLE: DISCARDED. J-VAC RESERVOIR 450 ML (2162) : LOT/LOT NUMBER: JU1321. LIST ALL J&J PRODUCTS THAT WERE USED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. THE RESERVOIR DID NOT VACUUM AFTER THE MANIPULATION OF THE BREAK, THE INDICATED PLACE TO HOLD THE DRAIN WAS ESCAPING THE VACUUM. AS REPORTED, AFTER THE RESERVOIR WAS REPLACED, THE VACUUM WAS RESTORED. WAS THERE ANY DAMAGE OR INJURY REPORTED BY THE PATIENT OR USER? NO. WAS THERE A SIGNIFICANT DELAY ? NO. IF AVAILABLE, PLEASE PROVIDE THE PRODUCT ORDER NUMBER (PO). THE PHOTO UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. NO PRODUCT IS AVAILABLE FOR RETURN. 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 (B)(6) 2026 AND A RESERVOIR WAS USED. THE RESERVOIR DID NOT MAKE THE VACUUM AFTER MANIPULATING THE BREAK. THEY INDICATED TO HOLD THE DRAIN WAS ESCAPING THE VACUUM. ACCORDING TO THE REPORT, AFTER CHANGING THE RESERVOIR, THE VACUUM WAS RESTORED.