BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUT ACIFLEX*2-0 45CM 1AG.CP-35

    MDR report key: 22195440 · Received June 12, 2025

    Report

    Report Number
    2210968-2025-06709
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    October 23, 2024
    Report Date
    July 17, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    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, 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: THE COMPLAINT IN QUESTION WAS RECEIVED THROUGH AN ANONYMOUS REPORT, SO WE DON'T HAVE THE CONTACT INFORMATION OF THE COMPLAINANT AND WE DON'T HAVE THE ANSWERS TO THE QUESTIONS BELOW. WHERE WAS THE FOREIGN MATERIAL FOUND? (INSIDE THE STERILE BARRIER OR OUTSIDE OF THE STERILE BARRIER?) PLEASE DESCRIBE THE TYPE OF FOREIGN MATTER THAT WAS OBSERVED. WHAT WAS THE FOREIGN MATTER¿S APPEARANCE? WHAT WAS THE TEXTURE? ARE THERE ANY PHOTOS OF THE FOREIGN MATTER AVAILABLE? IS IT POSSIBLE THAT THE FOREIGN MATERIAL FELL INTO PACKAGING UPON OPENING OF DEVICE? WAS THE PRODUCT SEAL ON THE FOIL STILL INTACT WHEN THE PACKAGE WAS OPENED? WILL THE DEVICE BE RETURNED FOR EVALUATION? IF YES PLEASE RETURN ALL RELEVANT PACKAGING MATERIAL . WAS THE PROCEDURE COMPLETED WITHOUT ANY ADVERSE EFFECT TO THE PATIENT? PLEASE CONFIRM THE LOT NUMBER OF THE PRODUCTS INVOLVED IN THIS COMPLAINT: PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS: 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. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) CORRECTED INFORMATION: D4 LOT, ADDITIONAL INFORMATION: D 4. PRIMARY UDI NUMBER. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THE LOT NUMBER PROVIDED, BRRM51921, IS INVALID. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024 AND SUTURE WAS USED. DURING THE PROCEDURE, WHEN OPENING THE PACKAGE, DIRT IS OBSERVED ON TWO PARTS OF THE ACIFLEX WIRE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362004 SUT ACIFLEX*2-0 45CM 1AG.CP-35 SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE GAQ ETHICON INC. BRRM51921

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown