ETHILON

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4) 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. PLEASE CONFIRM, WHEN DID THE ALLEGED DEFICIENCY OCCUR (REMOVAL FROM PACKAGE / DURING HANDLING PRIOR TO USE ON PATIENT/ DURING PASSAGE THROUGH TISSUE / DURING TYING / POST-OP)? IF DIFFERENT, PLEASE EXPLAIN. DID THIS EVENT CONTRIBUTE TO ANY PATIENT ADVERSE EVENT? IF YES, PLEASE EXPLAIN. PLEASE PROVIDE THE TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (E.G. NURSE, SURGEON, RISK MANAGER). NO PRODUCT IS AVAILABLE FOR RETURN. 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 SURGERY ON (B)(6) 2026 AND SUTURE WAS USED. 0/0 SUTURE NEEDLE SEPARATED FROM THREAD WHEN HOLDING IT WITH THE NEEDLE HOLDER TO FIXATE IT ON SHARPS BOX FOAM PAD. HAVING PINNED TO THE SURROUNDING. INFORMED SURGEON THAT NEEDLE SEPARATED FROM THREAD AND PINNED TO SURROUNDINGS WHEN TRYING TO HOLD IT ON THE SHARPS BOX. SURGEON CONFIRMED WAS NOT IN OR ON THE EYE. PATIENT WAS AWAKE AND AWARE OF. DEVICE AVAILABILITY IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.