BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL+ UD 27IN 5-0 S/A RB-1

    MDR report key: 22532400 · Received July 17, 2025

    Report

    Report Number
    2210968-2025-08277
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    January 1, 2025
    Report Date
    September 3, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031051645
    PMA / PMN Number
    K132580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. 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. THERE WERE NO CHANGES TO THE PATIENT¿S CARE NOR COMPLICATIONS. LC IS THE UROLOGY COORDINATOR WHO INFORMED ME AND PROVIDED INFO.

    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. ADDITIONAL INFORMATION: H6, D9, H3. H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. FORTY-ONE UNOPNED FOIL PACKETS WERE RECEIVED FOR ANALYSIS. PRODUCT CODE IS VCP213H. FOLLOWING THE SAMPLING PLAN, A VISUAL INSPECTION WAS CONDUCTED ON (B)(4) SAMPLES. THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT ISSUES. ALTHOUGH, THE SUTURES IN ALL THE SAMPLES WERE NOTED WITH SIGNIFICANT DIFFERENCE IN SUTURE¿S DIAMETER AND COLORATION AT THE TIPPING AREA. AS PER THIS CONDITION OBSERVED IN THE SUTURES, A FLEX TEST WAS PERFORMED ON THE FORTY-ONE SAMPLES. ALL SUTURES WERE BREAKING AWAY FROM THE SWAGE AREA. IN FURTHER INVESTIGATION, NO ISSUES RELATED TO FRAYING SUTURE WERE OBSERVED DURING EVALUATION. BASED ON THE INFORMATION CURRENTLY AVAILABLE, DAMAGED SUTURE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH THE ETHICON QUALITY SYSTEM. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: I HAVE NOT RECEIVED ANY COMPLAINT INFO REGARDING THE J SUTURE MENTIONED IN THE ABOVE EMAIL. MY BELIEF IS THIS WAS MISTAKENLY INCLUDED. L, CAN YOU CONFIRM THAT YOU HAVE ONLY HAD ISSUE WITH THE VCP CODE, NOT THE J CODE. ISSUE WITH ONLY THE 1.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UROLOGY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE POPPED OFF THE SUTURE STRAND VERY QUICKLY/EASILY. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH CARE/ATTENTION IN HANDLING. THERE WAS A SHORT (MINUTES) DELAY IN THE COMPLETION OF THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615250 VCL+ UD 27IN 5-0 S/A RB-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UBMHRZ 10705031051645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown