J-VAC

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. DID THE REPORTED ISSUE CONTRIBUTE TO ANY PATIENT ADVERSE CONSEQUENCES? DID THE J-VAC RESERVOIR COME IN CONTACT WITH SURGICAL INSTRUMENTS, SURGICAL NEEDLES, SUTURES, SHARP OBJECTS AT ANY TIME? HOW WAS THE CASE COMPLETED? COULD YOU PLEASE PROVIDE THE LOT NUMBER? COULD YOU KINDLY PERFORM THE FOLLOW-UP ATTEMPT FOR THE PRODUCT RETURN? PLEASE ENSURE THAT THE SHIPMENT TRACKING NUMBER IS PROVIDED. HOW MANY DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY? DID THE EVENT OCCUR DURING ONE OR MULTIPLE PATIENT PROCEDURES? WHAT IS THE TOTAL NUMBER OF PROCEDURES? HAVE ANY OF THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF SO, COULD YOU PLEASE PROVIDE THE CORRESPONDING REFERENCE NUMBER(S)? PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: 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 AND A RESERVOIR WAS USED. IT SHOWED A BREAK IN THE COLLECTOR BAG, NEEDING TO BE REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.