BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EB EXC GRN 30IN 2-0 S/A V-7

    MDR report key: 22889468 · Received August 25, 2025

    Report

    Report Number
    2210968-2025-09771
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    January 1, 2025
    Report Date
    August 28, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    UDI-DI
    10705031058460
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: G07002 - DEVICE EVALUATION PENDING. 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. THE DEVICE UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: PRODUCT CODE: X964H, LOT 10230R. - PRODUCT CODE: X964H, LOT 103XUE. BOTH ITEMS WERE HANDED TO ME BY THE CUSTOMER AND IT WAS COMMUNICATED FROM THE CUSTOMER THAT BOTH ITEMS HAD THE SAME EXACT ISSUES. THERE IS NO DIFFERENCE BETWEEN THE ITEMS AS FAR AS COMPLAINT GOES. I DID NOT OPEN AN ADDITIONAL COMPLAINT AS THEY BOTH HAD THE SAME ISSUE BUT I AM HAPPY TO IF NEEDED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: ¿ WHERE WAS THE FOREIGN MATERIAL FOUND? (INSIDE SHIPPING BOX, INSIDE IMPLANT BOX, DIRECTLY ON DEVICE?) ¿ FOREIGN MATERIAL IS LOCATED ON THE NEEDLE ITSELF. ¿ PLEASE DESCRIBE THE TYPE OF FOREIGN MATTER THAT WAS OBSERVED. ¿ THE FOREIGN MATERIAL APPEARS TO BE BLACK IN COLOR. SEEMS LIKE A SOOT CONSISTENCY OR BURN MARK ON THE NEEDLE BODY. ¿ ARE THERE ANY PHOTOS OF THE FOREIGN MATTER AVAILABLE? ¿ YES PHOTOS ARE ATTACHED AND ITEM HAS BEEN PICKED UP BY THE REP AND WAITING FOR RETURN SHIPPER KIT TO BE SENT. ¿ IS IT POSSIBLE THAT THE FOREIGN MATERIAL FELL INTO PACKAGING UPON OPENING OF DEVICE? ¿ NEGATIVE. THE OR STAFF OPENED THE NEEDLE IN THE OR TO UTILIZE THE NEEDLE IN SURGERY WHEN IT WAS DISCOVERED. ¿ WAS THE SEALS ON THE FOIL STILL INTACT WHEN THE PACKAGE WAS OPENED? ¿ YES HOWEVER THE FACILITY DOES NOT HAVE THE BOX OR FOIL PACKING JUST THE STERILE PAPER COVER. ¿ WAS ANY HOLE, PUNCTURE, OR TEAR FOUND (KIT CARTON, PRE-FILLED SYRINGE PACKAGING, OR TIP PACKAGING). ¿ NO. THEY STAFF DID INSPECT OTHER NEEDLES FROM THE LOT NUMBERS AND HAD NO ISSUES EXCEPT FOR ONE OTHER NEEDLE THAT APPEARED TO HAVE A SIMILAR CONSISTENCY ON IT/DISCOLORATION. ¿ WHERE WAS THE HOLE, PUNCTURE, OR TEAR FOUND (KIT CARTON, PRE-FILLED SYRINGE PACKAGING, OR TIP PACKAGING). ¿ NO ¿ 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. ¿ DEVICE HAS BEEN PICKED UP BY REP AND REMAINS IN MY POSSESSION. AWAITING SHIPPER KIT TO BE SENT TO MY ADDRESS TO RETURN THE EFFECTED ITEM FOR FURTHER PROCESSING NOTE BODY (LOCAL LANGUAGE).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 8/28/2025. 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. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. ADDITIONAL INFORMATION: D9, H3, H6. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE LABELED WINDING FORMER WITH A NEEDLE SUTURE COMBINATION. TO EVALUATE THE CONDITION OF THE RETURNED SAMPLE, THE NEEDLE SUTURE WAS REMOVED FROM THE TRAY AND NO FOREIGN MATTER COULD BE OBSERVED DURING THE EVALUATION. AS PART OF ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THE NEEDLE ITSELF HAS A BLACK CODING. DEVICE IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1617044 EB EXC GRN 30IN 2-0 S/A V-7 SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC. 103XUE 10705031058460

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown