BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILK BLK 40IN 2 S/A KP-3 CONV

    MDR report key: 24436396 · Received February 24, 2026

    Report

    Report Number
    2210968-2026-01963
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    January 1, 2025
    Report Date
    February 24, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE DETACHED NEEDLE AND ONE DISPENSED SUTURE WERE RECEIVED FOR ANALYSIS. PRODUCT CODE W794G. DURING EXAMINATION, A SHORT INSERTION LENGTH WAS OBSERVED AT THE SUTURE END, AND NO REMNANT WAS FOUND WITHIN THE NEEDLE BARREL HOLE. VISUAL INSPECTION DETERMINED THAT THE NEEDLE AND SUTURE WERE DETACHED BECAUSE THE SUTURE INSERTION DID NOT MEET THE SPECIFIED ACCEPTANCE CRITERIA. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THE SHORT INSERTION ISSUE WAS IDENTIFIED AS PULL OUT DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH THE ETHICON QUALITY SYSTEM. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. "D4/G4: DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THEREFORE, (01) GTIN IS NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PNEUMONECTOMY PROCEDURE IN 2025 AND SUTURE WAS USED. BEFORE USE, SCRUB NURSE WENT TO LOAD ONE OF THESE SUTURES AND THE SUTURE JUST CAME AWAY FROM THE NEEDLE. NOT USED ON PATIENT SO NO ISSUE. IT WAS IN A PNEUMONECTOMY. NEXT ONE OUT OF THE SAME PACKET WAS FINE. DURING EXAMINATION, A SHORT INSERTION LENGTH WAS OBSERVED AT THE SUTURE END, AND NO REMNANT WAS FOUND WITHIN THE NEEDLE BARREL HOLE. VISUAL INSPECTION DETERMINED THAT THE NEEDLE AND SUTURE WERE DETACHED BECAUSE THE SUTURE INSERTION DID NOT MEET THE SPECIFIED ACCEPTANCE CRITERIA. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THE SHORT INSERTION ISSUE WAS IDENTIFIED AS PULL OUT DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495680 SILK BLK 40IN 2 S/A KP-3 CONV SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE GAP ETHICON INC. 108ZT7

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown