BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD VIO 36IN 1 S/A CP

    MDR report key: 21003812 · Received December 23, 2024

    Report

    Report Number
    2210968-2024-13922
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    November 18, 2024
    Report Date
    December 23, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. 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. 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. HOW LONG WAS THE DELAY? PLEASE SPECIFY IN MINUTES. WAS THERE ANY CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP OR LOC/BQ). PLEASE PERFORM AND DOCUMENT THE FOLLOW UP ATTEMPT FOR PRODUCT RETURN. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER IN NOTES OR RMAO SECTIONS. UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP OR LOC/BQ).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A C-SECTION PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, USE OF A VICRYL THREAD THAT BROKE WHILE TYING KNOTS DURING A CAESAREAN SECTION OVERJET OF THE APONEUROSIS WITH AN ANGLE STITCH. USE OF A SECOND THREAD (SAME REFERENCE, SAME LOT) AND THE INCIDENT OCCURRED AGAIN DURING THE SAME PROCEDURE. IMMEDIATE ACTION: WITHDRAWAL OF DEVICES FROM THE SAME LOT (UDBCZJA0) AND SUTURE CHANGE TO A NEW LOT. IMMEDIATE CONSEQUENCES: SOME CONCERN ABOUT THE RISK OF VENTRATION. STRESS FOR THE NURSE WHO HAD TO LEAVE THE ROOM TO LOOK FOR A NEW BOX. LONGER OPERATING TIME. NO IMPACT ON THE PATIENT, AS THE SUTURE BROKE AT THE CORNER. 21 UNUSED SUTURES: WITHDRAWAL OF THE BATCH AND THEREFORE ECONOMIC IMPACT FOR THE DEPARTMENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627311 VCL CT BRD VIO 36IN 1 S/A CP SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UDBCZJA0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown