BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS C VIOLET 2/0 (3) 25M

    MDR report key: 8290276 · Received January 30, 2019

    Report

    Report Number
    3003639970-2019-00074
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Report Date
    January 30, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    NEW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012. REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, (B)(4) MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K031216. MANUFACTURING SITE EVALUATION: ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED ONE OPEN AND USED CASSETTE WITHOUT CAP AND WITH THE DATE OF CASSETTE'S OPENING WRITTEN (B)(6) 2018. THE RECEPTION OF THE CASSETTE WAS ON 21.01.2019, SO THE SUTURE WAS USED WITHIN 4 MONTHS PERIOD AFTER OPENING, WHICH IS CORRECT. THREAD IN THE CASSETTE RECEIVED BREAKS EASILY; THE THREAD IS DEGRADED. THREAD DEGRADES BY HYDROLYSIS BECAUSE OF AIR HUMIDITY. STABILITY TESTS PERFORMED GUARANTEE PRODUCT PROPERTIES WITHIN 4 MONTH AFTER OPENING THE CASSETTE. REVIEW OF THE BATCH MANUFACTURING RECORD SHOWED THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B.BRAUN SURGICAL REQUIREMENTS. REMARKS: AS INDICATED ON THE CASSETTE LABEL, "KNOT THE REMAINING THREAD AND REPLACE THE CAP AFTER EACH USE". FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE SAMPLE RECEIVED DOES NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE SAMPLE RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE MONOPLUS SUTURE AT A VETERINARY CLINIC. IT WAS NOTED THAT THE SUTURE BREAKS TOO EASILY WHEN BEING PULLED OUT OF THE CASSETTE, AND THE CASSETTE HAD BEEN OPENED ON (B)(6) 2018. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83811 MONOPLUS C VIOLET 2/0 (3) 25M SYNTHETIC ABSORBABLE MONOFILAR NEW B.BRAUN SURGICAL SA F0024272 117303

    Patients

    Seq Age Sex Outcome Treatment
    1