J-VAC*RESV. 150 ML

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. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT IS THE LOT NUMBER? UNK.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. IT WAS STATED THAT NEGATIVE PRESSURE IS OFTEN NOT INITIATED IN THE ICU AFTER SURGERY. THE FLAP OF THE 150ML RESERVOIR IS OFTEN FORGOTTEN TO BE RELEASED, AND THE NURSES ARE THOROUGHLY INSTRUCTED ON THIS, BUT IT IS THOUGHT THAT IT IS DIFFICULT TO DETERMINE WHETHER THE RESERVOIR IS SWOLLEN OR NOT WITH A 150ML RESERVOIR. THEREFORE, ALTHOUGH 150ML IS CURRENTLY SUFFICIENT CONSIDERING THE DRAINAGE VOLUME, THEY HAVE DECIDED TO CHANGE TO A 300ML RESERVOIR AND OPERATE IT ACCORDINGLY. FOR PATIENTS, 150ML IS COMPACT AND JUST RIGHT, BUT THEY THINK THAT THE 300ML RESERVOIR IS A BETTER CHOICE TO PREVENT DRAINAGE FAILURE. THE CUSTOMER THINKS THAT THE 150ML LOCK HOLE PART WOULD BE MARKED IN RED OR SOME OTHER COLOR TO MAKE IT EASIER TO TELL WHETHER IT'S LOCKED OR NOT. ANOTHER PRODUCT WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.