BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS C VIOLET 2/0 (3) 25M

    MDR report key: 14571872 · Received June 2, 2022

    Report

    Report Number
    3003639970-2022-00225
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Report Date
    June 2, 2022
    Manufacturer
    B. BRAUN SURGICAL, S.A.
    Product Code
    NEW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICE OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. UNDER PMA/510(K) NUMBER: K031216. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED ONE OPEN CASSETTE THAT EXPIRED 1 YEAR AGO (EXPIRY DATE ON 25 MAY 2021). ALSO, THE DATE OF CASSETTE'S OPENING IS NOT WRITTEN. AS STATED ON THE CASSETTE LABEL: ONCE OPENED, THE CONTENT OF THE CASSETTE SHOULD BE USED WITHIN 4 MONTHS AND PRIOR TO EXPIRATION DATE. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE CASSETTE RECEIVED IS ALREADY EXPIRED, WE CONCLUDE THAT THE COMPLAINT IS NOT CONFIRMED. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, THERE IS NO NEED TO ESTABLISH CORRECTIVE OR PREVENTIVE ACTIONS. NEVERTHELESS, THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED AN ISSUE WITH MONOPLUS C SUTURE. THE CLIENT REPORTED THAT THE THREAD BROKE WHEN THE USER TRIED TO PULL THE THREAD OUT OF THE CASSETTE AND THEREFORE IT COULD NOT BE USED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184873 MONOPLUS C VIOLET 2/0 (3) 25M SYNTHETIC ABSORBABLE MONOFILAR SUTURE NEW B. BRAUN SURGICAL, S.A. F0024272 119483

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown