BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD UD 36IN 1 S/A CT-1

    MDR report key: 19464185 · Received June 4, 2024

    Report

    Report Number
    2210968-2024-05813
    Event Type
    Malfunction
    Date Received
    June 4, 2024
    Date of Event
    January 1, 2024
    Report Date
    July 3, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031043688
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (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 H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. THE RETURNED SAMPLE DETERMINED THAT IT WAS RECEIVED, TWO UNOPENED SAMPLES THAT PERTAIN TO THE PRODUCT CODE J947. TO EVALUATE THE CONDITION OF THE RETURNED SAMPLES, THE PACKETS WERE OPENED. THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND NO ANOMALIES WERE OBSERVED DURING THE EVALUATION. THE FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT AND THE PULL FORCE RESULT WAS ABOVE THE MINIMUM REQUIREMENTS. 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. THE FOLLOWING INFORMATION WAS RECEIVED: THE FACILITY WAS ABLE TO PROVIDE TWO AFFECTED SUTURES. I AM SHIPPING BACK TODAY. PLEASE KEEP THIS COMPLAINT OPEN AS THE SUTURE WILL BE RECEIVED BACK TO BE ANALYZED SHORTLY.

    Additional Manufacturer Narrative · 0

    (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. IT WAS REPORTED THAT THE SUTURE USED INTRA-OP WAS NOT KEPT, HOWEVER, UNOPENED STRANDS ARE LEFT FROM THE SAME LOT NUMBER. ATTEMPTS ARE BEING MADE TO RETRIEVE THE SAMPLES. TO DATE NO DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. MULTIPLE SIZE 1 SUTURES WERE ACTING LIKE POP-OFFS (CONTROLLED RELEASE) AND THE SUTURE WAS NOT SUPPOSED TO BE CONTROLLED RELEASE. THEY WERE NOT ACTING LIKE MULTIPLE PASS SUTURE. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814074 VCL CT BRD UD 36IN 1 S/A CT-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UAMETQ 10705031043688

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown