BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SFX SYM PDS+ UNI VIO 18IN 1 S/A CT

    MDR report key: 16595329 · Received March 22, 2023

    Report

    Report Number
    2210968-2023-01957
    Event Type
    Malfunction
    Date Received
    March 22, 2023
    Date of Event
    February 19, 2023
    Report Date
    March 22, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    UDI-DI
    10705031227682
    PMA / PMN Number
    K113004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: COULD YOU PLEASE CLARIFY IF THE PATIENT SUFFERED FROM ANY SIGNS OR CONSEQUENCES DUE TO THE ISSUE? THERE IS NO REPORT ON PATIENT'S INJURY. NO ADDITIONAL INFORMATION COULD BE PROVIDED. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. THE RETURNED PRODUCT DETERMINED THAT ONE DETACHED NEEDLE, AND ONE SUTURE IN USE CONDITION THAT PERTAINS TO PRODUCT CODE SXPP1A405 WAS RECEIVED. DURING VISUAL INSPECTION OF THE RETURNED SAMPLE, MARKS THAT APPEAR TO BE CAUSED BY A SURGICAL INSTRUMENT WERE OBSERVED ON THE BODY NEEDLE. THE SUTURE WAS EXAMINED, AND THE ENDS OF THE SUTURE WERE NOTED TO BE CUT PROBABLY CAUSED BY A SURGICAL INSTRUMENT. IN ADDITION, BODY FLUIDS WERE NOTED ALONG THE STRAND. THE OTHER SECTION OF THE SUTURE WAS NOT RETURNED FOR ANALYSIS. AS PER CONDITIONS OF THE RETURNED SAMPLE, NO FUNCTIONAL TEST COULD BE PERFORMED. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH ¿ = 2360 G/M. 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) 2023 AND BARBED SUTURE WAS USED. THE SUTURE WAS BROKEN WHEN SEWING. CHANGED ANOTHER ONE TO COMPLETE THE SURGERY. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427279 SFX SYM PDS+ UNI VIO 18IN 1 S/A CT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. SXPP1A405 UNK 10705031227682

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown