BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD UD 18IN 4-0 S/A P-2 PRM

    MDR report key: 18416497 · Received December 29, 2023

    Report

    Report Number
    2210968-2023-10236
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Date of Event
    December 1, 2023
    Report Date
    December 28, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031040731
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 12/28/2023. H6 COMPONENT CODE: G07002 - NO DEVICE PROBLEM FOUND. 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. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: - PLEASE CONFIRM IF ALL 13 SUTURES INVOLVED HAD BENT AND DETACHED DURING SURGERY: YES, THAT IS CORRECT. - PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: SUSANNE SAWYER, RN H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. THE RETURNED SAMPLE DETERMINED THAT IT WAS RECEIVED ONE UNOPENED SAMPLE THAT PERTAIN TO THE PRODUCT CODE J504G. UPON INITIAL INSPECTION, OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE PACKET. IN ORDER TO EVALUATE THE CONDITIONS OF THE RETURNED SAMPLE, THE PACKET WAS OPENED, AND NO DEFECTS WERE DETECTED. THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. IN ADDITION, THE TIP AND BODY OF THE NEEDLES WERE EXAMINED, AND NO ANOMALIES OR ISSUES RELATED TO BENT NEEDLES COULD BE OBSERVED DURING THE EVALUATION. THE SUTURE WAS DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND TO DETECT ANY ISSUE RELATED NO DEFECTS WERE OBSERVED DURING EVALUATION. A FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT AND THE PULL FORCE RESULT WAS ABOVE THE MINIMUM REQUIREMENTS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. RELATED REPORTS: 2210968-2023-10223, 2210968-2023-10224, 2210968-2023-10227, 2210968-2023-10228, 2210968-2023-10230, 2210968-2023-10231, 2210968-2023-10232, 2210968-2023-10234, 2210968-2023-10235, 2210968-2023-10237, 2210968-2023-10240, 2210968-2023-10242.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN EYE PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING AN EYE PROCEDURE, NEEDLE IS BENDING AND DETACHING. AT THE TIME OF THE CALL THE CASE WAS ONGOING, THE SURGEON HAD GONE THROUGH THIRTEEN SUTURES. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2245878 VCL CT BRD UD 18IN 4-0 S/A P-2 PRM SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. TBMKLR 10705031040731

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown