J-VAC*RESV. 300 ML

Additional Manufacturer Narrative

PRODUCT COMPLAINT #(B)(4). CORRECTED INFORMATION: B1, H1 - THIS MEDWATCH REPORT IS BEING VOIDED AS THIS DEVICE WAS NOT INVOLVED IN THE REPORTED EVENT.

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 D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. -UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DURING SURGERY, THE DRAIN WAS REMOVED AND REPLACED WITH AN ANOTHER PRODUCT, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. WAS THE ISSUE NOTICED DURING FIRST ACTIVATION? UNK WAS ANOTHER DRAIN NEEDED TO CORRECT THE SITUATION? YES IF YES, WAS THE NEW DRAIN PLACED SURGICALLY DURING A SECOND PROCEDURE? UNK COULD YOU PLEASE PROVIDE THE BLAKE DRAIN LOT NUMBER? J2217326. COULD YOU PLEASE PROVIDE THE J-VAC RESERVOIR LOT NUMBER? UNK. 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.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A RESERVOIR WAS USED. DURING THE PROCEDURE, CLOGGING OCCURRED INSIDE OF THE DRAIN. ANOTHER DRAIN WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.