BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCRYL VIO 27IN 0 S/A CT-1

    MDR report key: 14570841 · Received June 1, 2022

    Report

    Report Number
    2210968-2022-04219
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    April 5, 2022
    Report Date
    June 1, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    UDI-DI
    10705031058866
    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). (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. SAMPLE ANALYSIS: VISUAL ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT ONE OPENED SAMPLE PRODUCT CODE Y340H WAS RECEIVED TO ETHICON INC FOR EVALUATION. THE STRAND WAS BROKEN IN SEVERAL PIECES DURING THE INSPECTION DUE TO THE DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. THE PRODUCT CODE Y340H CONTAINS AN ABSORBABLE SUTURE. AS THE PACKAGE WAS RECEIVED OPEN, THE TIME OF EXPOSED TO THE ENVIRONMENT COULD NOT BE DETERMINED AND FUNCTIONAL TEST CANNOT BE PERFORMED. THE FOIL WAS VISUALLY INSPECTED, AND EXCESSIVE WRINKLES 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 BATCH. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCE'S WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, IT WAS REPORTED BY A SALES REP THAT, DURING AN UNKNOWN SURGERY, WHEN THE PACKAGE WAS OPENED, THE SUTURE WAS FOUND TO HAVE BEEN TORN INTO SEVERAL MILLIMETERS BEFORE USE. UPON EVALUATION OF THE RETURNED SAMPLE, THE FOIL WAS VISUALLY INSPECTED, AND EXCESSIVE WRINKLES AND HOLES IN THE CAVITY WERE OBSERVED. THIS CONDITION CONTRIBUTED TO THE DEGRADATION OF THE SUTURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2197563 MCRYL VIO 27IN 0 S/A CT-1 SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. Y340H LPZ225 10705031058866

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown