BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL CT BRD VIO 30IN 2-0 S/A LH

    MDR report key: 19096686 · Received April 12, 2024

    Report

    Report Number
    2210968-2024-04229
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Date of Event
    January 1, 2024
    Report Date
    July 24, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031129146
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 5/14/2024. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: - WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (RE-OPERATION; RE-SUTURING; RE-CLOSURE; DRAINAGE)? IF SO, PLEASE SPECIFY. IT HAD TO BE RE-STITCHED AND CLOSED AGAIN. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? THE EXTENSION OF THE OPERATION PERIOD DID NOT CAUSE ANY PROBLEMS. WHAT TISSUE WAS BEING SUTURED WHEN THE EVENT OCCURRED? THEY ARE USED UNDER THE SKIN AND IN FASCIA. WAS ADDITIONAL DISSECTION REQUIRED IN OTHER ORGANS/TISSUES OTHER THAN THE TARGET TISSUE? NO WAS THERE ANY CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? NO WHAT IS THE CURRENT STATUS OF THE PATIENT? DISCHARGED PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS (NOT THE PERSON RELAYING/SUBMITTING ANSWERS TO LOC OR CHU). THE NURSE IN CHARGE 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

    (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. - PLEASE CLARIFY: IS SUTURE BREAKAGE OCCURRED OR NEEDLE PULL OFF? - IT WAS REPORTED PATIENT CONSEQUENCES, WAS THERE ANY ADVERSE CONSEQUENCE ASSOCIATED WITH THE PATIENT? - IT WAS REPORTED ADDITIONAL MEDICAL INTERVENTIONS, WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (RE-OPERATION; RE-SUTURING; RE-CLOSURE; DRAINAGE)? IF SO, PLEASE SPECIFY. - WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? - WHAT TISSUE WAS BEING SUTURED WHEN THE EVENT OCCURRED? - WAS ADDITIONAL DISSECTION REQUIRED IN OTHER ORGANS/TISSUES OTHER THAN THE TARGET TISSUE? - WAS THERE ANY CHANGE IN THE PATIENT¿S POST OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? - WHAT IS THE CURRENT STATUS OF THE PATIENT? ATTEMPTS ARE BEING 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. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED RELATED EVENTS CAPTURED VIA: 2210968-2024-04227 2210968-2024-04228 2210968-2024-04229.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2024 AND SUTURE WAS USED. THE SUTURE BROKE AT THE JUNCTION WITH THE NEEDLE. THE SUTURE IS VERY WEAK AND BREAKS EASILY. THE SURGERY WAS DELAYED BY 20 MINUTES DUE TO THE EVENT AND WAS COMPLETED WITH ANOTHER BRAND OF SUTURE. THERE WERE NO DETAILS REPORTED ABOUT THE CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838114 VCL CT BRD VIO 30IN 2-0 S/A LH SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. SJBCMDR0 10705031129146

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown