BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD VIO 36IN 0 S/A CT-1

    MDR report key: 17210384 · Received June 27, 2023

    Report

    Report Number
    2210968-2023-04663
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    May 18, 2023
    Report Date
    June 27, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031039117
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3 DEVICE ANALYSIS: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. THE RETURNED PRODUCT DETERMINED THAT IT WAS RECEIVED, A SUTURE PIECE THAT PERTAIN TO THE PRODUCT CODE J346H. DURING VISUAL INSPECTION OF THE RETURNED SAMPLE, THE EXTREMES OF THE SUTURE WERE NOTED TO BE CUT PROBABLY CAUSED BY A SURGICAL INSTRUMENT. IN ADDITION, BODY FLUIDS WERE NOTED ALONG THE STRAND. THE OTHER SECTION OF THE SUTURE WAS NOT RETURNED FOR ANALYSIS. THIS PRODUCT CODE CONTAINS AN ABSORBABLE SUTURE AND THE TIME OF EXPOSURE OF THE SUTURE IN THE ENVIRONMENT COULD NOT BE DETERMINED. THEREFORE, THE FUNCTIONAL TEST COULD NOT BE PERFORMED. THE INSTRUCTIONS FOR USE DO CONTAIN THE FOLLOWING CAUTION: AS WITH ANY DEVICE, CARE SHOULD BE TAKEN TO AVOID DAMAGE TO THE STRAND WHEN HANDLING. AVOID THE CRUSHING OR CRIMPING ACTION OF SURGICAL INSTRUMENTS, SUCH AS NEEDLE HOLDERS AND FORCEPS. AS PART OF THE ETHICON QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A C SECTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, IT WAS REPORTED TO THE SALES REP BY THE SURGICAL TECH THAT THE SUTURE BROKE DURING A CONTINUOUS SUTURE LINE WHILE TYING THE KNOT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929814 VCL CT BRD VIO 36IN 0 S/A CT-1 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. J346H SPBCXJZ0 10705031039117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown