BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON* BLK 4-0 45CM (1)SC-20

    MDR report key: 21211051 · Received January 22, 2025

    Report

    Report Number
    2210968-2025-00838
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    January 1, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. 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 WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: COULD YOU PLEASE PROVIDE THE ATTACHMENTS FOR THE PRODUCTS TRACEABILITY INFORMATION FROM EDC AND RDC? I DO NOT KNOW WHAT YOU MEAN BY ¿THE ATTACHMENTS¿, BUT WE HAVE REQUESTED THE TRACEABILITY TO SOURCING SITE BASED UPON BATCH NUMBERS. HOW WAS THE PRODUCT PURCHASED? WITH SUPPORT OF A THIRD-PARTY SERVICES PROVIDER IN VENEZUELA, CONTACT WAS MADE WITH COMPANIES / INDIVIDUALS CLAIMING TO SELL ETHICON BRANDED SUTURES. SUBSEQUENTLY, SAME THIRD-PARTY VENDOR ACQUIRED THE PRODUCTS. IS THERE AN INDICATION OF HOW THE PRODUCT WAS DISTRIBUTED? NOT AT THIS TIME, THE INTENT OF THE INVESTIGATION IS TO GET TO UNDERSTAND ILLICIT TRADE PRODUCTS ROUTE. IS THERE ANY INDICATION OF THE SOURCE? ALL SUSPECT PRODUCTS BATCH NUMBERS INDICATE PRODUCTS MANUFACTURED BY J&J BRAZIL AND DISTRIBUTED TO SEVERAL COUNTRIES IN LATIN AMERICA, THOSE DO NOT INCLUDE VENEZUELA HOWEVER. BASED ON THE PACKAGING, IS THERE ANY INDICATION OF WHICH MARKET THE ORIGINAL GENUINE PRODUCT MAY HAVE COME FROM? YES, DEFINITELY THE ORIGINAL PRODUCTS COME FROM LATIN AMERICA MARKET, AND COLOMBIA SEEMS TO BE THE MOST PROBABLY SOURCE AS IT HAS RECEIVED / DISTRIBUTED THE VAST MAJORITY OF THE LOTS, BUT AT THIS TIME THERE ARE NO HARD ELEMENTS THAT CAN ASSURE COLOMBIA AS THE SOURCE. WERE THE DEVICE USED ON A PATIENT? IF SO, WAS THERE ANY PATIENT CONSEQUENCE? NO, NONE OF THE PRODUCTS HAVE BEEN USED ON A PATIENT, THOSE WERE ACQUIRED FOR INVESTIGATIVE PURPOSES ONLY. H3 ANALYSIS SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE UNOPENED SAMPLE THAT PERTAINS TO PRODUCT CODE 14502T, LOT: 347954 WAS RECEIVED FOR ANALYSIS. UPON INITIAL INSPECTION OF THE SAMPLE, NO EXTERNAL DAMAGES WERE OBSERVED ON THE EXTERNAL PACKET. PICTURES OF THE PRODUCT RECEIVED WERE PROVIDED TO ETHICON RARITAN TO PERFORM A COMPARISON WITH THE ARTWORK IN THE SYSTEM. THE SAMPLE WAS NOTED TO BE ACCORDING TO THE MANUFACTURING PROCESS. HOWEVER, THE LOT NUMBER PRINTED (347954) DOES NOT BELONG TO THE PRODUCT CODE 14502T. ALSO, THE PACKETS CONTAIN A FOLDER OF PRODUCT CODE 14502T WITH ONE NEEDLE/SUTURE COMBINATION THAT BELONGS TO ETHILON SUTURE. BESIDES THAT, A CHARACTERIZATION WAS PERFORMED WITH THE FOLLOWING RESULTS: THE NEEDLE IS SALES TYPE SC-20, 3/8 CIRCLE, SILVER COLOR, (ETHIPOINT). THE SUTURE BELONGS TO DIAMETER 4-0 ETHILON MONOFILAMENT¿ AND LENGTH 45CM AND BLACK COLOR. THE DIVERSION PRODUCT, COUNTERFEIT AND TAMPERING IS CONFIRMED, SINCE THE LOT NUMBER PRINTED PERTAINS TO A DIFFERENT PRODUCT CODE. ETHICON PRODUCT WAS NOT DISTRIBUTED BY AN AFFILIATE AUTHORIZED. THE TRACEABILITY REPORT WAS NOT PROVIDED. BASED ON THE SAMPLES RECEIVED, THE PRODUCT IS CONFIRMED FOR COUNTERFEIT DUE TO THE DISCREPANCIES FOUND IN THE LABELING AND PACKAGING MATERIAL. FOR THE REMAINING PRODUCT EXPERIENCE CODE, NO INFORMATION IS AVAILABLE TO CONFIRM THE PREVIOUS ONES. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. D4: UDI: AS A VALID LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MARKET SURVEY IS BEING PERFORMED IN VENEZUELA, IN THE CITY (B)(6), 10 DIFFERENT NON-AUTHORIZED AND SUSPICIOUS SELLERS. THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. ONE UNOPENED SAMPLE THAT PERTAINS TO PRODUCT CODE 14502T, LOT: 347954 WAS RECEIVED FOR ANALYSIS. UPON INITIAL INSPECTION OF THE SAMPLE, NO EXTERNAL DAMAGES WERE OBSERVED ON THE EXTERNAL PACKET. PICTURES OF THE PRODUCT RECEIVED WERE PROVIDED TO ETHICON RARITAN TO PERFORM A COMPARISON WITH THE ARTWORK IN THE SYSTEM. THE SAMPLE WAS NOTED TO BE ACCORDING TO THE MANUFACTURING PROCESS. HOWEVER, THE LOT NUMBER PRINTED (347954 ) DOES NOT BELONG TO THE PRODUCT CODE 14502T. ALSO, THE PACKETS CONTAIN A FOLDER OF PRODUCT CODE 14502T WITH ONE NEEDLE/SUTURE COMBINATION THAT BELONGS TO ETHILON SUTURE. BESIDES THAT, A CHARACTERIZATION WAS PERFORMED WITH THE FOLLOWING RESULTS: THE NEEDLE IS SALES TYPE SC-20, 3/8 CIRCLE, SILVER COLOR, (ETHIPOINT). THE SUTURE BELONGS TO DIAMETER 4-0 ETHILON MONOFILAMENT¿ AND LENGTH 45CM AND BLACK COLOR. THE DIVERSION PRODUCT, COUNTERFEIT AND TAMPERING IS CONFIRMED, SINCE THE LOT NUMBER PRINTED PERTAINS TO A DIFFERENT PRODUCT CODE. ETHICON PRODUCT WAS NOT DISTRIBUTED BY AN AFFILIATE AUTHORIZED. THE TRACEABILITY REPORT WAS NOT PROVIDED. BASED ON THE SAMPLES RECEIVED, THE PRODUCT IS CONFIRMED FOR COUNTERFEIT DUE TO THE DISCREPANCIES FOUND IN THE LABELING AND PACKAGING MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572929 ETHILON* BLK 4-0 45CM (1)SC-20 SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown