BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL CT BRD UD 30IN 3-0 S/A FS-2

    MDR report key: 21159651 · Received January 15, 2025

    Report

    Report Number
    2210968-2025-00537
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    January 1, 2024
    Report Date
    February 7, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. 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: INDEED, WE ENCOUNTERED A SUTURE PROBLEM DURING A SURGICAL PROCEDURE. THE 3 SUTURES LOOSENED DURING THE SAME PROCEDURE YES. THIS HAD NO CONSEQUENCES FOR THE PATIENT BUT IT IMPACTED OUR CARE BECAUSE IT OCCURRED DURING THE REALIZATION OF AN OVERJET, WHICH WE HAD TO RESUME SEVERAL TIMES (WASTE OF TIME IN PARTICULAR). I DIDN'T THINK OF WRITING DOWN THE LOT NUMBER. 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. WHEN DID THE NEEDLE PULL-OFF OCCUR: WAS THE NEEDLE SEPARATED DURING DISPENSING, BUT BEFORE USE ON THE PATIENT? OR WAS THE NEEDLE PREMATURELY RELEASED FROM THE SUTURE STRAND DURING USE ON THE PATIENT?

    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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHEN DID THE NEEDLE PULL-OFF OCCUR: WAS THE NEEDLE SEPARATED DURING DISPENSING, BUT BEFORE USE ON THE PATIENT? WAS THE NEEDLE PREMATURELY RELEASED FROM THE SUTURE STRAND DURING USE ON THE PATIENT? INDEED, WE ENCOUNTERED A SUTURE PROBLEM DURING A SURGICAL PROCEDURE. THE 3 SUTURES LOOSENED DURING THE SAME PROCEDURE YES. THIS HAD NO CONSEQUENCES FOR THE PATIENT BUT IT IMPACTED OUR CARE BECAUSE IT OCCURRED DURING THE REALIZATION OF AN OVERJET, WHICH WE HAD TO RESUME SEVERAL TIMES (WASTE OF TIME IN PARTICULAR). I DIDN'T THINK OF WRITING DOWN THE LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE, THE THREAD PULLED OFF/LOOSENED FROM THE SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1583680 VICRYL CT BRD UD 30IN 3-0 S/A FS-2 SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown