BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSORBABLE SURGICAL SUTURE USP

    MDR report key: 21087214 · Received January 6, 2025

    Report

    Report Number
    2210968-2025-00188
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    October 22, 2024
    Report Date
    January 6, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031142299
    PMA / PMN Number
    K032420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE PAPER LID, ONE EMPTY WINDING FORMER, ONE NEEDLE AND SEVERAL SUTURE PIECES THAT PERTAINED TO PRODUCT CODE VP2304. DURING THE VISUAL INSPECTION OF THE RETURNED SAMPLE, IT WAS NOTED THAT THE SUTURE PIECES HAD BEGUN WITH A DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. THE FOIL WAS NOT RETURNED TO ANALYSIS. THE PRODUCT CODE VP2304 CONTAINS AN ABSORBABLE SUTURE. AS THE SAMPLE WAS RECEIVED OPEN, THE TIME OF EXPOSURE TO THE ENVIRONMENT COULD NOT BE DETERMINED AND THE FUNCTIONAL TEST COULD NOT BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: WERE THERE PATIENT CONSEQUENCES? IF YES, PLEASE SPECIFY - NO. - NAME OF PROCEDURE ¿ NOT KNOWN. NOTE: PLEASE MENTION THE SOURCE THROUGH WHICH THE INFORMATION IS RECEIVED (INFORMATION RECEIVED FROM DR, NURSE ETC. ¿ (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6)2024 AND SUTURE WAS USED. DURING THE PROCEDURE, DURING SURGERY WHEN THE SURGEON OPENED FOIL, THE SUTURE WAS CUT INTO PIECES IN THE FOIL AND IT HAPPENED IN 2 FOILS OF THE SAME BATCH. THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE PAPER LID, ONE EMPTY WINDING FORMER, ONE NEEDLE AND SEVERAL SUTURE PIECES THAT PERTAINED TO PRODUCT CODE VP2304. DURING THE VISUAL INSPECTION OF THE RETURNED SAMPLE, IT WAS NOTED THAT THE SUTURE PIECES HAD BEGUN WITH A DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. THE FOIL WAS NOT RETURNED TO ANALYSIS. THE PRODUCT CODE VP2304 CONTAINS AN ABSORBABLE SUTURE. AS THE SAMPLE WAS RECEIVED OPEN, THE TIME OF EXPOSURE TO THE ENVIRONMENT COULD NOT BE DETERMINED AND THE FUNCTIONAL TEST COULD NOT BE PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360328 ABSORBABLE SURGICAL SUTURE USP SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. T2024 10705031142299

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown