FIBRIN SEALANT PREPARATION DEVICE

Additional Manufacturer Narrative

PRODUCT COMPLAINT#: (B)(4). D4 UDI NUMBER: UDI/GTIN UNAVAILABLE AS THIS DEVICE IS FROM A KIT. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. HOW MANY DEVICES DEMONSTRATED THE ALLEGED DEFICIENCY? WHAT IS THE LOT NUMBER OF EACH INVOLVED DEVICE? WAS THE PRODUCT USED ON THE PATIENT? ARE THERE PICTURES OF THE DAMAGED DEVICE(S) AVAILABLE? THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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 THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND HEMOSTATIC AGENT DUAL APPLICATOR DEVICE WAS USED. DURING THE PROCEDURE, THE LUER LOCK DEVICE BROKE WHILE ATTACHING THE LAPAROSCOPIC TIP. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.