Additional Manufacturer Narrative · 0
(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-UP REPORT WILL BE FILED AS APPROPRIATE. H3 ANALYSIS SUMMARY: NEUCHÂTEL TEAM RECEIVED FOR EVALUATION A PRODUCT TVTO DEVICE (PRODUCT CODE 810081), BATCH 3942680. THE PRODUCT WAS DECONTAMINATED AND WELL PACKAGED. THE RECEIVED DEVICE WAS MANIPULATED, AS PARTS OF THE ORIGINAL PACKAGING WERE MISSING (BOX, BLISTER, IFU, NEEDLES, HANDLES AND ATRAUMATIC WINGED GUIDE. IT WAS ONLY RETURN A LID WITH IDENTIFICATION LABEL, THE BLUE MESH CUT IN 2 PARTS, BOTH PLASTIC SHEATH. MESH AND SHEATHES WERE COVERED WITH ORGANIC MATTER AROUND. EVALUATION OF RECEIVED DEVICE: -LID WAS RECEIVED WITH THE LOT LABEL: PRODUCT CODE 810081, BATCH 3942680 -BLUE MESH -IT WAS OBSERVED THAT THE MESH WAS COVERED WITH ORGANIC MATTER, FOLD AND CURLED. -ALSO THE MESH HAS BEEN CUT IN 2 PART. -THE MESH HAS BEEN EXTENDED, STITCHES OF THE MESH WERE THORN/ SHREDDED ON THE EDGES. THE 2 PLASTIC SHEATH WERE COVERED WITH ORGANIC MATTER AND SENT SEPARATED FROM ITS MESH, AND MESH AND PLASTIC SHEATHES WERE BEEN CUTTED OUT FROM THE NEEDLES. THE DEFECT DESCRIBED IN THE EVENT DESCRIPTION IS ALIGNED WITH THE DEFECTS SEEN ON THE DEVICE DURING THE PRODUCT EVALUATION, HOWEVER, THE DEFECTS IDENTIFIED DURING THE PRODUCT EVALUATION ARE NOT LINKED TO A MANUFACTURING ISSUE.