BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML

    MDR report key: 7522951 · Received May 17, 2018

    Report

    Report Number
    3003639970-2018-00277
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Report Date
    May 17, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: THERE ARE NO SAMPLES AVAILABLE. ANALYSIS AND RESULTS: AS NO BATCH NUMBER IS KNOWN, THE BATCH MANUFACTURING RECORD CANNOT BE REVIEWED. HAVE NOT RECEIVED ANY SAMPLE FOR ANALYSIS. WITHOUT ANY SAMPLES AN ANALYSIS CAN NOT BE CARRIED OUT IN ORDER TO MAKE A DECISION. FINAL CONCLUSION: COMPLAINT IS NOT JUSTIFIED. WITHOUT ANY CLOSED SAMPLES A STUDY CAN NOT BE PERFORMED TO SEE IF THE AFFECTED PRODUCT DOES NOT FULFILL THE OEM REQUIREMENTS. NOTE IS TAKEN OF THIS INCIDENT AND IF ANY SAMPLES ARE RECEIVED IN THE FUTURE, THE CASE WILL BE RE-OPENED AND ANALYZED. 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. THIS REPORT IS BEING SUBMITTED LATE DUE TO MIS-INTERPRETATION OF 2 YEAR PRESUMPTION ACKNOWLEDGEMENT AND AGREEMENT BY FDA. ONCE ISSUE WAS IDENTIFIED, RETROSPECTIVE REVIEW OF COMPLAINTS WAS COMPLETED FROM TIME OF 2 YEAR PRESUMPTION IMPLEMENTATION TO PRESENT. ALL REPORTS IDENTIFIED ARE BEING REPORTED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: JAPAN. IT WAS REPORTED THAT THE PRIMARY PACKAGES ARE EMPTY. THERE IS NO GLUE IN THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365271 HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050052

    Patients

    Seq Age Sex Outcome Treatment
    1 Other