BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL VIO 18IN 4-0 S/A P-3 PRM MP

    MDR report key: 15289267 · Received August 24, 2022

    Report

    Report Number
    2210968-2022-06904
    Event Type
    Malfunction
    Date Received
    August 24, 2022
    Date of Event
    June 24, 2022
    Report Date
    August 24, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031059269
    PMA / PMN Number
    K960653
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. DEVICE ANALYSIS: VISUAL ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT AN EMPTY OPENED FOIL, A NEEDLE IN A LABELED WINDING FORMER AND SEVERAL SUTURE PIECES OF PRODUCT CODE Y464G WERE RECEIVED TO ETHICON FOR EVALUATION. THE SUTURE HAS BEGUN WITH PROCESS DEGRADATION CAUSED BY EXPOSURE TO THE ENVIRONMENT AND THE NEEDLE DETACHED FROM THE STRAND. THE PRODUCT CODE Y464G CONTAINS AN ABSORBABLE SUTURE. AS THE SAMPLE WAS RECEIVED OPEN, THE TIME OF EXPOSURE TO THE ENVIRONMENT COULD NOT BE DETERMINED AND FUNCTIONAL TESTS CANNOT BE PERFORMED. THE FOIL PACKET WAS VISUALLY INSPECTED, AND EXCESSIVE WRINKLES, DELAMINATION, AND HOLES IN THE CAVITY WERE OBSERVED. THIS CONDITION CONTRIBUTED TO THE DEGRADATION OF THE SUTURE. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT/BATCH. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A QUADRANTECTOMY AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS FOUND THAT THE NEEDLE WAS DETACHED FROM THE SUTURE BEFORE USE. IT WAS NOT A CONTROL RELEASE NEEDLE. UPON EVALUATION OF THE DEVICE, THE SUTURE HAS BEGUN WITH PROCESS DEGRADATION CAUSED BY EXPOSURE TO THE ENVIRONMENT AND THE NEEDLE DETACHED FROM THE STRAND. AS THE SAMPLE WAS RECEIVED OPEN, THE TIME OF EXPOSURE TO THE ENVIRONMENT COULD NOT BE DETERMINED AND FUNCTIONAL TESTS CANNOT BE PERFORMED. THE FOIL PACKET WAS VISUALLY INSPECTED, AND EXCESSIVE WRINKLES, DELAMINATION, AND HOLES IN THE CAVITY WERE OBSERVED. THIS CONDITION CONTRIBUTED TO THE DEGRADATION OF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440771 MCRYL VIO 18IN 4-0 S/A P-3 PRM MP SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. Y464G LHM085 10705031059269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown