BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD VIO 27IN 0 S/A CTX

    MDR report key: 11518702 · Received March 18, 2021

    Report

    Report Number
    2210968-2021-02499
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    March 3, 2021
    Report Date
    March 2, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031039315
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #: (B)(4). DATE SENT TO THE FDA: 05/06/2021. 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. INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION RECEIVED, OPEN HYSTERECTOMY WHILST TYING & CLOSING UTERINE VESSEL WITH 0 VICRYL J346H SUTURE MATERIAL SNAPPED. THE PRODUCT WAS RETURNED TO ETHICON INC FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TEST EVALUATION WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT ELEVEN UNOPENED SAMPLES OF PRODUCT CODE J364H WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE UNOPENED SAMPLES NO DEFECTS WERE FOUND ON THE PACKAGE. THE SAMPLES WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WAS NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND AND NO DEFECTS, DAMAGE, OR SUTURE BREAKAGE WERE NOTED. A FUNCTIONAL TEST WAS PERFORMED AND THE TENSILE STRENGTH FORCE WAS ABOVE THE MINIMUM REQUIREMENT. THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. 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. THIS REPORT IS NOT INTENDED TO DENY THAT YOU EXPERIENCED A PROBLEM WITH THE DEVICE. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVENTS REPORTED IN (B)(4), 2210968-2021-02500, 2210968-2021-02501, 2210968-2021-02502, 2210968-2021-02503 ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER PDK402, AND NO NON-CONFORMANCES WERE IDENTIFIED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN OB-GYN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE WHILE TRYING TO CLOSE THE UTERINE VESSEL. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414432 VCL CT BRD VIO 27IN 0 S/A CTX SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. J364H PDK402 10705031039315

    Patients

    Seq Age Sex Outcome Treatment
    1