BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EB EXC WHT 30IN USP2-0 D/A V-5 MP

    MDR report key: 23115536 · Received September 22, 2025

    Report

    Report Number
    2210968-2025-10812
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    January 1, 2025
    Report Date
    September 22, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: - WHEN WERE THE SUTURES CUT (IN THE PACKAGE, DURING REMOVAL FROM PACKAGE, DURING HANDLING PRIOR TO USE ON PATIENT OR DURING USE ON THE PATIENT)? PLEASE SPECIFY - COULD YOU KINDLY PERFORM THE FOLLOW-UP ATTEMPT FOR THE PRODUCT RETURN? PLEASE ENSURE THAT THE SHIPMENT TRACKING NUMBER IS PROVIDED - PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: IT WAS REPORTED TO ME THAT THE SUTURES WERE BELIEVED TO BE CUT OUT OF THE PACKAGE. I HAVE NOT BEEN ABLE TO IDENTIFY TO SCRUB TECH WHO WAS IN THE ROOM WHEN IT HAPPENED. (PLEASE REFER TO THE ATTACHED EMAIL) IS THE PERSON WHO HAS PROVIDING ME INFORMATION. THERE IS NOT PRODUCT AVAILABLE TO BE SENT BACK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIOVASCULAR PROCEDURE ON (B)(6) 2025 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP THAT THE SUTURE WAS CUT IN THE HALF OUT OF THE PACKAGE. THEY USED ANOTHER SUTURE TO COMPLETE THE PROCEDURE. DEVICE ARE NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542490 EB EXC WHT 30IN USP2-0 D/A V-5 MP SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC. 105DUP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown