BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLENE BLUE 0.7M 45CM W/NDL

    MDR report key: 22554581 · Received July 21, 2025

    Report

    Report Number
    2210968-2025-08398
    Event Type
    Malfunction
    Date Received
    July 21, 2025
    Date of Event
    June 1, 2025
    Report Date
    July 21, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) H3 PHOTO INVESTIGATION SUMMARY: THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTO SHOWS A NEEDLE ON A TAPE INSIDE A PLASTIC BAG. THE SUTURE IS NOT VISIBLE IN THE IMAGE. A CLEAR ANALYSIS COULD NOT BE PERFORMED AS THE PHOTO BECOMES DISTORTED WHEN MAGNIFIED. BASED ON THE PHOTO REVIEW, THE EVENT REPORTED IS NOT CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. BECAUSE THE DEVICE WAS NOT RETURNED OUR EVALUATION IS LIMITED. WE VALUE THE OPPORTUNITY TO FULLY ANALYZE THE DEVICE UPON ITS RETURN. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. H3 PHOTO INVESTIGATION SUMMARY: THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTO SHOWS A NEEDLE ON A TAPE INSIDE A PLASTIC BAG. THE SUTURE IS NOT VISIBLE IN THE IMAGE. A CLEAR ANALYSIS COULD NOT BE PERFORMED AS THE PHOTO BECOMES DISTORTED WHEN MAGNIFIED. BASED ON THE PHOTO REVIEW, THE EVENT REPORTED IS NOT CONFIRMED, HOWEVER NO CONCLUSION OR ROOT CAUSE COULD BE DETERMINED. HANDS ON DEVICE ANALYSIS MAY PROVIDE THE ADDITIONAL EVIDENCE NECESSARY TO CONFIRM THE ROOT CAUSE OF THE REPORTED EVENT. BECAUSE THE DEVICE WAS NOT RETURNED OUR EVALUATION IS LIMITED. WE VALUE THE OPPORTUNITY TO FULLY ANALYZE THE DEVICE UPON ITS RETURN. AS PART OF ETHICON QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. D4: UDI: (01) GTIN UNAVAILABLE, PRODUCT MADE PRIOR TO GTIN COMPLIANCE DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ORAL EMERGENCY PROCEDURE IN (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE BROKE WHEN SEWING IN SURGERY. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SUTURE WAS BROKEN WHEN THE SURGEON ATTEMPTED TO SEW THE TISSUE. TOTAL 4 PRODUCTS OCCURRED NEEDLE BREAKAGE ISSUE, AND 4 PRODUCTS OCCURRED SUTURE BREAKAGE ISSUE. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. THERE IS NO REPORT ON PATIENT'S INJURY. ENCLOSED PLEASE FIND DEFECT PHOTO. NO ADDITIONAL INFORMATION COULD BE PROVIDED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2753160 PROLENE BLUE 0.7M 45CM W/NDL SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. 102LT7

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown