STLESS STEEL SIL 4X18IN 7 S/A CCS

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 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. ADDITIONAL INFORMATION: H6, ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: CAN YOU IDENTIFY THE LOT NUMBER OF THE PRODUCT USED? NO. WAS THE BLACK DEBRIS FOUND INSIDE THE STERILE PACKAGING? YES. WERE THERE ANY ISSUES WITH THE SEAL OF THE STERILE PACKAGING? NOT REPORTED. ARE THERE ANY TEARS/HOLES IN THE STERILE PACKAGING? NOT REPORTED. PLEASE PROVIDE THE STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS. ( I DID SEND BACK, SORRY TRACKING INFORMATION NOT AVAILABLE) PLEASE PROVIDE THE TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (E.G. NURSE, SURGEON, RISK MANAGER) (PLEASE REFER THE ATTACHED EMAIL. CORRECTED DATA: H11 MRE / DHR WAS PREVIOUS REPORTED IN ERROR. NO LOT WAS PROVIDED.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. * CAN YOU IDENTIFY THE LOT NUMBER OF THE PRODUCT USED? * WAS THE BLACK DEBRIS FOUND INSIDE THE STERILE PACKAGING? * WERE THERE ANY ISSUES WITH THE SEAL OF THE STERILE PACKAGING? * ARE THERE ANY TEARS/HOLES IN THE STERILE PACKAGING? H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE STRAIGHT PACKET WITH FOUR NEEDLE SUTURE COMBINATIONS THAT PERTAINS TO PRODUCT CODE M655G WAS RECEIVED FOR ANALYSIS. THIS PRODUCT CODE IS MULTI-STRANDS AND CONTAINS FOUR STRANDS SINGLE ARMED PER PACKET. UPON VISUAL ASSESSMENT OF THE RETURNED SAMPLE AN UNKNOWN BLACK FOREIGN MATTER WAS FOUND ON THE NEEDLES AND INSIDE THE STRAIGHT PACKET. BASED ON THE INFORMATION CURRENTLY AVAILABLE, A FOREIGN MATTER ISSUE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH THE QUALITY SYSTEM. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. THERE WAS BLACK DEBRIS NOTICED OUTSIDE THE RUBBER PROTECTOR OF THE NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.