BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORBABLE SURGICAL SUTURE USP

    MDR report key: 16357585 · Received February 10, 2023

    Report

    Report Number
    2210968-2023-00979
    Event Type
    Malfunction
    Date Received
    February 10, 2023
    Date of Event
    December 12, 2022
    Report Date
    March 9, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION EVALUATION WAS CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ONE OPENED SAMPLE THAT PERTAINS TO THE PRODUCT CODE VP2346 WAS RECEIVED FOR EVALUATION. UPON VISUAL ASSESSMENT OF THE SUTURE, IT WAS OBSERVED THAT THE STRAND HAS BEGUN WITH A DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. THIS CONDITION CONTRIBUTES TO THE NEEDLE SEPARATING FROM THE SUTURE. THE FOIL WAS VISUALLY INSPECTED, AND EXCESSIVE WRINKLES AND HOLES IN THE CAVITY WERE OBSERVED DUE TO HANDLING. PER THE SAMPLE CONDITION, THE FUNCTIONAL TEST CANNOT BE PERFORMED. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2022 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, WHILE CLOSING RECTUS SHEATH SURGEON OPENED THE FOIL AND FOUND THAT THE NEEDLE IS SEPARATED FROM SUTURE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ONE OPENED SAMPLE THAT PERTAINS TO THE PRODUCT CODE VP2346 WAS RECEIVED FOR EVALUATION. UPON VISUAL ASSESSMENT OF THE SUTURE, IT WAS OBSERVED THAT THE STRAND HAS BEGUN WITH A DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. THIS CONDITION CONTRIBUTES TO THE NEEDLE SEPARATING FROM THE SUTURE. THE FOIL WAS VISUALLY INSPECTED, AND EXCESSIVE WRINKLES AND HOLES IN THE CAVITY WERE OBSERVED DUE TO HANDLING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46636 ABSORBABLE SURGICAL SUTURE USP SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. T0003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown