BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL+ VIO 27IN 2-0 S/A CT-1

    MDR report key: 20046801 · Received August 23, 2024

    Report

    Report Number
    2210968-2024-08810
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 22, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031052475
    PMA / PMN Number
    K132580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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 ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: ATTACHED "ADDT INFO" FILE, SINCE ATTEMPTED TO CONFIRM WITH REPORTER ABOUT THE NUMBER OF EVENTS/PRODUCTS INVOLVED: Q: CAN YOU SUPPORT CONFIRMING THAT THE REPORTED PROBLEM HAPPENED WITH 2 SUTURES? THE PHOTOGRAPH SHOWS 4 DISASSEMBLED NEEDLES. A: THE DOCTOR REPORTED THAT THIS HAPPENED WITH SEVERAL SUTURES, BUT ONLY REPORTED 2 SAMPLES OF THE ONES USED, THE OTHERS WERE DISCARDED. IF ADDITIONAL CLARIFICATION IS RECEIVED, THE RECORD WILL BE UPDATED. Q:"DO YOU KNOW IF IT HAPPENED WITH SEVERAL SUTURES IN DIFFERENT SURGICAL PROCEDURES?" A: "IT HAPPENED WITH SEVERAL SUTURES IN THE SAME EVENT, OF WHICH ONLY 2 SAMPLES WERE REPORTED (WHICH ARE THE ONES WE HAVE PHYSICALLY TO SEND), THE OTHERS WERE DISCARDED BY THE DOCTOR." ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: ¿ WHAT WAS THE PROCEDURE CALLED? PLASTIC SURGERY ¿ WHAT WAS THE DATE OF THE PROCEDURE? (B)(6) 2024. ¿ WHAT IS THE LOT NUMBER? AU2627. ¿ DEVICE RETURN STATUS: POOR CONDITION, NON-COMPLIANT ¿ WHEN WAS THE NEEDLE DETACHED OR REMOVED FROM THE SUTURE (IN THE PACKAGE, DURING REMOVAL OF THE PACKAGE, DURING MANIPULATION PRIOR TO USE ON THE PATIENT, OR DURING USE ON THE PATIENT)? DURING. ¿ WHAT WAS USED TO COMPLETE THE PROCEDURE? ANOTHER SUTURE, FROM ANOTHER BOX. ¿ PLEASE CLARIFY THE NUMBER OF SUTURES INVOLVED IN THE EVENT AND HOW MANY WILL BE RETURNED. 2 SUTURES. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL PATIENT EVENTS. ATTEMPTS WERE MADE TO OBTAIN THE INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD DETACHED FROM THE NEEDLE. IT DISASSEMBLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380569 VCL+ VIO 27IN 2-0 S/A CT-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. AU2627 10705031052475

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown