BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD VIO 27IN 1 S/A CT-1

    MDR report key: 13090701 · Received December 27, 2021

    Report

    Report Number
    2210968-2021-12991
    Event Type
    Malfunction
    Date Received
    December 27, 2021
    Date of Event
    November 25, 2021
    Report Date
    March 22, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031039056
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 3/22/2022. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3 INVESTIGATIONAL NARRATIVE: VISUAL ANALYSIS OF THE RETURNED PRODUCT REVEALED THAT AN EMPTY FOIL PACKET, AN EMPTY LABELED WINDING FORMERS AND A NEEDLE/SUTURE PIECE PRODUCT CODE J341H WERE RECEIVED TO ETHICON INC FOR EVALUATION. THE STRAND WAS BROKEN AT SEVERAL PIECES DURING THE INSPECTION DUE TO THE DEGRADATION PROCESS CAUSED BY EXPOSURE TO THE ENVIRONMENT. THE PRODUCT CODE J341H CONTAINS AN ABSORBABLE SUTURE. AS THE PACKAGE WAS RECEIVED OPEN, THE TIME OF EXPOSED TO THE ENVIRONMENT COULD NOT BE DETERMINED AND FUNCTIONAL TEST CANNOT BE PERFORMED. THE FOIL WAS VISUALLY INSPECTED, AND EXCESSIVE WRINKLES AND HOLES IN CAVITY WERE OBSERVED. THIS CONDITION CONTRIBUTED TO DEGRADATION OF THE SUTURE. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. AS PART OF 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. 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 Manufacturer Narrative · 0

    PRODUCT COMPLAINT NUMBER: (B)(4). DATE SENT TO THE FDA: (B)(6) 2021. 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: WHAT WAS THE INITIAL PROCEDURE? TOTAL OPEN HYSTERECTOMY. COULD YOU CONFIRM IF THE PATIENT SUFFERS ANY CONSEQUENCE DUE TO THE PROBLEM (SUTURE BREAK)? IF YES, PLEASE EXPLAIN. THERE IS NO REPORT FROM THE DOCTOR ABOUT ANY CONSEQUENCES. 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 RELATED TO: 2210968-2021-12988, 2210968-2021-12989, 2210968-2021-12990.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL OPEN HYSTERECTOMY ON (B)(6) 2021 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE BROKE. TWO UNITS WOULD BE USED, BUT WHEN THESE BROKE ANOTHER TWO WERE USED, AND THE SAME THING HAPPENED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1984822 VCL CT BRD VIO 27IN 1 S/A CT-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. J341H AP5228 10705031039056

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown