BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOSYN UNDYED 4/0(1,5)70CM DS19 (M) RCP

    MDR report key: 7790637 · Received August 16, 2018

    Report

    Report Number
    3003639970-2018-00453
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    May 28, 2018
    Report Date
    October 4, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    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 MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING PENDING FURTHER INFORMATION.

    Additional Manufacturer Narrative · 0

    SAMPLES RECEIVED: THERE ARE NO SAMPLES AVAILABLE. 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 NOT RECEIVED ANY SAMPLE TO ANALYZE THIS COMPLAINT. WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. REVIEWED THE BATCH MANUFACTURING RECORD, THE PRODUCT HAS AN INTERNAL INCIDENCE RELATED TO OTHER ISSUE, AND IT WAS RELEASED INTO THE MARKET FULFILLING USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. 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. REPORTED DEVICE IS NOT MARKETED IN THE US, HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS, OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE US. REFER TO 510(K) K011375 FOR A SIMILAR DEVICE CLEARED FOR US MARKETING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: PORTUGAL. IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL TO THE COMPANY SALES REPRESENTATIVE "THE MONOSYN WITH THE REFERENCE 2023404 WITH THE BATCH 118107, THE LAST ONE THAT WAS RECEIVED, SOME PACKS SHOW SOME DEFECTS. THE WIRE SPLITS NEAR TO THE NEEDLE. ONLY THIS MORNING, IT HAPPEN WITH 4 PACKS, WITH VARIOUS NEEDLE HOLDERS." ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 3003639970-2018-00518; 3003639970-2018-00519; 3003639970-2018-00520.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630223 MONOSYN UNDYED 4/0(1,5)70CM DS19 (M) RCP SUTURES GAM B.BRAUN SURGICAL SA C2023404 118107

    Patients

    Seq Age Sex Outcome Treatment
    1