BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL FLEX 0.5 ML

    MDR report key: 7522947 · Received May 17, 2018

    Report

    Report Number
    3003639970-2018-00276
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Date of Event
    December 27, 2017
    Report Date
    May 17, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    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 POUCH. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS. THERE ARE NO UNITS IN STOCK IN THE WAREHOUSE. RECEIVED ONE OPEN POUCH WITH AN UNOPENED AMPOULE INSIDE. AMPOULE SHOWS WHITE RESIDUES AS CAN BE SEEN IN THE ENCLOSED PICTURE. CUSTOMER HAS CONFIRMED THAT THE WHITE RESIDUES WERE PRESENT WHEN THEY OPENED THE POUCH. STORAGE TEMPERATURE IS NOT A POSSIBLE ORIGIN OF THE DEFECT BECAUSE THE PRODUCT IS STORED IN THE FRIDGE AND IN AIR CONDITIONED ROOM IN THE END CUSTOMER'S CLINIC. THE PHENOMENON OF THE WHITE RESIDUE IS KNOWN AS "BLOOMING" AND IT IS A KNOWN EFFECT IN CYANOACRYLATE PRODUCTS. IT APPEARS AS A CONSEQUENCE OF THE EVAPORATION OF THE CYANOACRYLATE. THE AMPOULE RECEIVED HAS A LIGHT DEVIATION IN THE TIP AREA AND THIS COULD CAUSE LEAKAGE THAT COULD PROMOTE THE EVAPORATION AND THE OCCURRENCE OF THE WHITE RESIDUES IN THE AMPOULE. NEVERTHELESS, IT CANNOT BE DETERMINED THE ORIGIN OF THE BENT TIP. CANNOT DISCARD THAT IT HAPPENED DURING TRANSPORTATION. ON THE OTHER HAND AND TAKING INTO ACCOUNT THAT NO OTHER COMPLAINTS HAVE BEEN RECEIVED WE CONSIDER THAT THIS IS AN ISOLATED UNIT. REVIEWED THE BATCH MANUFACTURING RECORDS THE PRODUCT HAD A NORMAL PROCESS AND THE RESULTS BEFORE RELEASING THE PRODUCT INTO THE MARKET FULFILLED THE OEM SPECIFICATIONS. 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 THERE WAS CRYSTALLIZATION, TIP IS BLOCKED BY CRYSTALLIZED GLUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365265 HISTOACRYL FLEX 0.5 ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1051250 217163N2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other