BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD VIO 27IN 0 S/A XLH

    MDR report key: 10643126 · Received October 7, 2020

    Report

    Report Number
    2210968-2020-07735
    Event Type
    Malfunction
    Date Received
    October 7, 2020
    Date of Event
    January 1, 2020
    Report Date
    September 16, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031041455
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 11/09/2020. ADDITIONAL INFORMATION: ADDITIONAL H-3 SUMMARY: AN EMPTY OPENED FOIL, AN EMPTY OPENED FOLDER AND FIVE UNOPENED SAMPLES OF PRODUCT WERE RECEIVED FOR EVALUATION. DURING THE VISUAL INSPECTION OF FIVE UNOPENED SAMPLES, NO DEFECTS WERE FOUND ON THE PACKAGES. THE SAMPLES WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG OF THE STRAND AND NO DEFECTS, DAMAGED, FRAYING OR SUTURE BREAKAGE WERE NOTED. THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED AND THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED FOR ANALYSIS. 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 · 1

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE MEM697 BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: IT WAS REPORTED "THE NURSE USED THE SUTURE. IT IS VERY EASY TO TEAR APART" PLEASE CLARIFY: PLEASE CLARIFY THE INTRA-OP EVENT: WHAT DOES IT MEAN THE SUTURE ¿TEAR APART¿? WAS THIS THE SUTURE BREAKAGE, FRAYING OR PULL OFF (DETACHED FROM THE NEEDLE)? FRAYING WHAT TISSUE WAS BEING APPROXIMATED OR SUTURED WHEN IT BROKE? NO INFORMATION. WHAT WAS USED TO COMPLETE THE PROCEDURE? NO INFORMATION. PROCEDURE NAME AND DATE? NO INFORMATION. EVENT DATE? NO INFORMATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE WAS VERY EASY TO TEAR APART. THE SUTURE FRAYED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105446 VCL CT BRD VIO 27IN 0 S/A XLH SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. J582G MEM697 10705031041455

    Patients

    Seq Age Sex Outcome Treatment
    1