BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VCL+ CT BRD VIO 27IN 2-0 S/A MH-1+

    MDR report key: 18213324 · Received November 27, 2023

    Report

    Report Number
    2210968-2023-09222
    Event Type
    Malfunction
    Date Received
    November 27, 2023
    Date of Event
    October 27, 2023
    Report Date
    November 27, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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, PART 4 SUBPART B. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: COULD YOU PLEASE CLARIFY IF THE SUTURE GOT BROKEN OR WAS THE NEEDLE THAT GOT BROKEN? PLEASE CONFIRM. THE SUTURE DETACHED FROM THE NEEDLE. COULD YOU PLEASE CLARIFY IF THE PATIENT SUFFERED FROM ANY SIGNS OR CONSEQUENCES DUE TO THE ISSUE? PLEASE PROVIDE MORE DETAILS. UNABLE TO COMMENT. WAS THERE ANY CHANGE IN THE PATIENT¿S POST-OPERATIVE CARE DUE TO THE PROLONGED PROCEDURE? UNABLE TO COMMENT. WERE THERE ANY UNEXPECTED OUTCOMES OR COMPLICATIONS AS A RESULT OF THE PROLONGED SURGERY TIME? UNABLE TO COMMENT. HOW LONG (IN MINUTES) DID THE SURGERY PROLONG? UNABLE TO COMMENT. WHAT IS THE LOT NUMBER & PRODUCT CODE? 2/0 VICRYL PLUS. LOT NO. THBDGZS0. EVENTS REPORTED VIA: 2210968-2023-092223 AND 2210968-2023-09221.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VASCULAR PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, THE 1ST 3 PACKS ALL DETACHED DURING A VASCULAR CASE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764743 VCL+ CT BRD VIO 27IN 2-0 S/A MH-1+ SUTURE, ABSORBABLE, NATURAL GAM ETHICON INC. THBDGZS0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown