BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL FLEXIBLE PACK 5

    MDR report key: 7522962 · Received May 17, 2018

    Report

    Report Number
    3003639970-2018-00275
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Date of Event
    November 16, 2017
    Report Date
    May 17, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: 1 OPEN UNIT. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH (B)(4) UNITS WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET. THERE ARE NO UNITS IN THE WAREHOUSE. RECEIVED ONE OPEN UNIT THAT HAS BEEN CHECKED AND A DEFECT HAS BEEN FOUND IN THE AMPOULE. BECAUSE OF THAT DEFECT, THE GLUE WAS LEAKED AND CRYSTALLIZED INSIDE THE AMPOULE DUE TO THE CRACK. THE AMPOULES MANUFACTURER HAS BEEN INFORMED ACCORDINGLY. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF SAMPLE RECEIVED DOES NOT FULFILL THE OEM SPECIFICATIONS, IT IS CONCLUDED THAT THE COMPLAINT IS JUSTIFIED. 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 WHEN OPENING THE PACKAGE, THE LEAKAGE FROM THE AMPULE WAS ALREADY CAUSED, THEREFORE THE PRODUCT WAS NOT ABLE TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366486 HISTOACRYL FLEXIBLE PACK 5 TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1051250P 217205N1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other