J-VAC*RESV. 150 ML

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. "EVENT DESCRIPTION? A FEW MINUTES AFTER COMPLETION OF THE OPERATION AND TRANSFER TO THE ICU, IT WAS NOTED THAT THE SURGICAL DRAIN WAS NOT FUNCTIONING WITH SUCTION, RESULTING IN SWELLING OF THE THYROID AREA DUE TO LACK OF DRAINAGE. DEVICE ISSUE IDENTIFIED? UPON INSPECTION, THE SURGEON NOTICED THAT THE SLIT IN THE DRAIN TUBING EXTENDED FROM THE SLIT AREA TOWARD THE PROXIMAL SIDE BEYOND THE BLACK MARKER, SUGGESTING A PRODUCT DEFECT. CLINICAL ACTION TAKEN ? THE DRAIN WAS REMOVED, AND THE PATIENT UNDERWENT RE-OPERATION UNDER GENERAL ANESTHESIA FOR DRAIN RE-PLACEMENT. PATIENT OUTCOME? THE PATIENT IS CURRENTLY RECOVERING WELL, AND THE PHYSICIAN REPORTS NO REMAINING CLINICAL CONCERNS. THE PATIENT IS UNDER OBSERVATION, WITH AN AGREEMENT TO REPORT ANY CHANGES IF THEY OCCUR. ADDITIONAL DEVICE OBSERVATION? WHEN ANOTHER PRODUCT FROM THE SAME LOT WAS OPENED, THE SLIT APPEARED NORMAL; HOWEVER, A BLUE INDENTATION WAS OBSERVED APPROXIMATELY 5 CM PROXIMAL TO THE BLACK MARKER. AS A PRECAUTION, THAT PRODUCT WAS NOT USED, AND A PRODUCT FROM A DIFFERENT LOT WAS SELECTED. PHYSICIAN¿S ASSESSMENT? THE SURGEON BELIEVES THE EVENT WAS CAUSED BY A PRODUCT DEFECT OF THE DRAIN TUBE, LEADING TO INSUFFICIENT SUCTION. SUSPECTED MECHANISM? BECAUSE THE EVENT OCCURRED IMMEDIATELY AFTER TRANSFER TO THE ICU, FLUID OR BLOOD ACCUMULATION DUE TO SUCTION FAILURE WAS SUSPECTED. REPORTING NOTE? THE PHYSICIAN EXPRESSED CONCERN THAT THIS EVENT MAY BE SIMILAR TO CASE AND REQUESTED AN EXPEDITED INVESTIGATION." 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 Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION PROVIDED: SINCE THIS EVENT OCCURRED IMMEDIATELY AFTER THE PATIENT WAS SENT TO THE ICU, IT IS THOUGHT TO BE DUE TO A STORAGE OF BODY FLUID OR BLOOD. 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. 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 ENT (EYES, NOSE, AND THROAT) SURGERY ON (B)(6) 2026 AND A RESERVOIR WAS USED. IT WAS FOUND IN THE ISU, THE DRAIN HAD NOT BEEN SUCTIONED A FEW MINUTES AFTER THE OPERATION. THE PATIENT'S THYROID GLAND SWELLED BECAUSE IT WAS NOT SUCTIONED. THE DOCTOR NOTICED THAT THE SLIT RAN FROM THE BLACK DOT TO THE BACK SIDE WHEN HE CHECKED THE DRAIN. THE DRAIN WAS REMOVED AND SURGERY PERFORMED UNDER TOTAL ANESTHESIA TO RE-INSERT IT. THE PATIENT IS CURRENTLY FEELING BETTER AND THE DOCTOR SAYS THAT THERE ARE NO PROBLEMS. THE SLIT LOOKED NORMAL, BUT THERE WAS A BLUE DENT 5 CM FROM THE BLACK SPOT ON THE BACK SIDE WHEN THE PRODUCT OF SAME LOT WAS OPENED. JUST TO BE SAFE, THE PRODUCT OF SAME LOT WON'T BE USED AND ONE FROM ANOTHER LOT WILL BE USED. FURTHER DETAILS ARE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.