BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL TISSUE ADHES.TRNS 0.5ML

    MDR report key: 7522959 · Received May 17, 2018

    Report

    Report Number
    3003639970-2018-00287
    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
    KS
    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: 2 OPEN POUCHES. 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 STOCK IN WAREHOUSE. RECEIVED THREE OPEN POUCHES, TWO OF THEM HAVE THE TIP BENT. ONE OF THE AMPOULES RECEIVED IS CORRECT. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL THE OEM REQUIREMENTS. REVIEWED THE RAW MATERIAL AMPOULES AND WE CANNOT COME TO A ROOT CAUSE OF THIS DEFECT, BENT TIP COULD BE GENERATED IN MANY POINTS FROM PRODUCTION PROCESS TO DISTRIBUTION. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE SAMPLES RECEIVED DO 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: SOUTH KOREA. IT IS WAS REPORTED THAT WHEN USER UNPACKED THE HISTOACRYL, THEY WERE SOLIDIFIED AND LEAKED WITH BENDED TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366481 HISTOACRYL TISSUE ADHES.TRNS 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050060 217382N1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other