BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATGUT CHROM 2-0 70CM (1)CT-1

    MDR report key: 20838329 · Received December 3, 2024

    Report

    Report Number
    2210968-2024-12786
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    January 1, 2024
    Report Date
    December 3, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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. CORRECTED INFORMATION: D9, H6. CORRECTED ANALYSIS SUMMARY: THIS IS AN ANALYSIS FOR A PHOTO SUBMITTED TO ETHICON FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTOS SHOW FIVE FOILS LABELED AS 811T. THE LOTS NUMBER PRINTED AR3050 DOES NOT BELONG TO THE PRODUCT CODE 811T. 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. CUSTOMER SUPPORT SERVICES CHECKED PRODUCT TRACEABILITY INFORMATION BUT NO SALES RECORDS WERE FOUND. 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. THE ACTUAL PRODUCT WAS NOT RETURNED.

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. COULD YOU PLEASE PROVIDE THE ATTACHMENTS FOR THE PRODUCTS TRACEABILITY INFORMATION FROM EDC AND RDC? - HOW WAS THE PRODUCT PURCHASED? - IS THERE AN INDICATION OF HOW THE PRODUCT WAS DISTRIBUTED? IS THERE ANY INDICATION OF THE SOURCE? BASED ON THE PACKAGING, IS THERE ANY INDICATION OF WHICH MARKET THE ORIGINAL GENUINE PRODUCT MAY HAVE COME FROM? WERE THE DEVICE USED ON A PATIENT? IF SO, WAS THERE ANY PATIENT CONSEQUENCE? DEVICE RETURN STATUS. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER: PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. TWO UNOPENED SAMPLES THAT PERTAINS TO PRODUCT CODE 811T, LOT AA3150 WERE 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 WERE NOTED TO BE ACCORDING TO THE MANUFACTURING PROCESS. HOWEVER, THE LOTS NUMBER PRINTED (AR3050 AND 1032597) DOES NOT BELONG TO THE PRODUCT CODE 811T. ALSO, THE PACKETS CONTAIN A FOIL PACKET OF PRODUCT CODE 811T WITH ONE NEEDLE/SUTURE COMBINATION THAT BELONGS TO GUT CHROMIC SUTURE. BESIDES THAT, A CHARACTERIZATION WAS PERFORMED WITH THE FOLLOWING RESULTS: THE NEEDLES ARE SALES TYPE CT-1, ½ CIRCLE, SILVER COLOR, (TAPER POINT). THE SUTURES BELONG TO DIAMETER 2-0 GUT CHROMIC MONOFILAMENT¿, LENGTH 70 CM, AND UNDYED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2024 AND SUTURE WAS USED. BEFORE USE ON THE PATIENT, GLOBAL BRAND PROTECTION LATAM TEAM HAS PERFORMED A MARKET SURVEY IN VENEZUELA, IN THE CITY (B)(6), 10 DIFFERENT NON-AUTHORIZED AND SUSPICIOUS SELLERS. ALL PRODUCTS BOUGHT ARE LISTED BELOW. PLEASE OPEN A PRODUCT COMPLAINT TO REGISTER THE MARKET SURVEY, CHECK PRODUCTS, BATCHES, MANUFACTURING AND EXPIRY DATES TO CONFIRM THE SUSPICIOUS OF COUNTERFEIT, DIVERSION OR TAMPERING. THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. TWO UNOPENED SAMPLES THAT PERTAINS TO PRODUCT CODE 811T, LOT AA3150 WERE 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 WERE NOTED TO BE ACCORDING TO THE MANUFACTURING PROCESS. HOWEVER, THE LOTS NUMBER PRINTED (AR3050 AND 1032597) DOES NOT BELONG TO THE PRODUCT CODE 811T. ALSO, THE PACKETS CONTAIN A FOIL PACKET OF PRODUCT CODE 811T WITH ONE NEEDLE/SUTURE COMBINATION THAT BELONGS TO GUT CHROMIC SUTURE. BESIDES THAT, A CHARACTERIZATION WAS PERFORMED WITH THE FOLLOWING RESULTS: THE NEEDLES ARE SALES TYPE CT-1, ½ CIRCLE, SILVER COLOR, (TAPER POINT). THE SUTURES BELONG TO DIAMETER 2-0 GUT CHROMIC MONOFILAMENT¿, LENGTH 70 CM, AND UNDYED 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. THERE WERE NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870979 CATGUT CHROM 2-0 70CM (1)CT-1 SUTURE, ABSORBABLE, NATURAL GAL ETHICON INC. AR3050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown