BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD UD 27IN 3-0 S/A SC-20

    MDR report key: 19014248 · Received April 1, 2024

    Report

    Report Number
    2210968-2024-03710
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Report Date
    May 9, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 4/1/2024. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: IT WAS REPORTED THAT 7 PROCEDURES WERE AFFECTED AND A EXPENDITURE RECORD OF 14 SUTURES. PLEASE CONFIRM THE NUMBER OF PROCEDURES WHERE THE NEEDLE BREAKS. PLEASE SPECIFY THE NUMBER OF NEEDLES AFFECTED PER PROCEDURE. PLEASE CONFIRM THE NUMBER OF PROCEDURES WHERE THE NEEDLE BENDS. PLEASE SPECIFY THE NUMBER OF NEEDLES AFFECTED PER PROCEDURE. WERE THERE ANY PATIENT CONSEQUENCES? PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF THE EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP). PLEASE PROVIDE THE STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS. THE FOLLOWING INFORMATION WAS RECEIVED: THANK YOU VERY MUCH WITH THE INFORMATION. HOWEVER, I WANT TO MAKE IT CLEAR THAT THERE ARE NO SAMPLES TO SUPPORT THE LIST OF OPEN CASES, SINCE THE CLIENT DOES NOT SAVE THE DEVICES USED AND NEITHER DO I ALLAY THE COMPLAINTS INDIVIDUALLY, BUT AS A SUMMARY OF THE CASES PRESENTED, WITHOUT LEAVING TRACEABILITY OF THE PATIENTS AND HEALTH PROFESSIONALS INVOLVED IN THE PROCEDURES.. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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. RELATED REPORTS: 2210968-2024-03707, 2210968-2024-03709, 2210968-2024-03711, 2210968-2024-03713, 2210968-2024-03714, 2210968-2024-03715, 2210968-2024-03716, 2210968-2024-03717, 2210968-2024-03718, 2210968-2024-03171, 2210968-2024-03169.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 5/9/2024. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 5/9/2024. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS UNDERWENT UNKNOWN PROCEDURES ON UNKNOWN DATES, AND SUTURE WAS USED. THE INSTRUMENTATION STAFF STATED THAT IN PROCEDURES WITH A LONG SECTION OF SUTURE WITH A SINGLE SUTURE, THE NEEDLE BROKE, AND THEY MUST USE ANOTHER ONE. IN SOME CASES, THE NEEDLE ONLY BENT. FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566427 VCL CT BRD UD 27IN 3-0 S/A SC-20 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. AU2494

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown