ETHICON

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, 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE UNOPENED SAMPLE WAS RECEIVED FOR ANALYSIS. PRODUCT CODE TPW32. DURING VISUAL INSPECTION OF THE RETURNED SAMPLE, THE NEEDLE WAS FOUND TO BE IMPROPERLY SECURED WITHIN THE FOLDER, WITH A PORTION OF THE SUTURE PROTRUDING OUTSIDE THE FOLDER PACKAGING. THE PROTRUDING SUTURE WAS LOCATED IN AN AREA THAT COULD NOT BE SEALED BY THE OVERWRAP. A SUBSEQUENT INSPECTION CONFIRMED THAT THE OVERWRAP PACKET REMAINED INTACT AND ITS INTEGRITY WAS NOT COMPROMISED. BASED ON THE INFORMATION CURRENTLY AVAILABLE, NEEDLE(S) OUT OF THE FOLDER/TRAY WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH THE ETHICON QUALITY SYSTEM.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2026 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT PRIOR TO THE PROCEDURE, THE FIELD OBSERVED AN OPENED PACKAGE OF SUTURE IN WHICH THE NEEDLE WAS LOOSE WITHIN THE PACKAGE. NO PATIENT CONSEQUENCES WERE REPORTED. THE DEVICE IS BEING RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.