BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML

    MDR report key: 8681294 · Received June 9, 2019

    Report

    Report Number
    3003639970-2019-00466
    Event Type
    Malfunction
    Date Received
    June 9, 2019
    Report Date
    July 17, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLES RECEIVED: 1 OPEN POUCH. ANALYSIS AND RESULTS: WE HAVE ONLY RECEIVED AN OPEN POUCH OF THE CODE-BATCH 1050052-213031N1. ACCORDING TO THE CUSTOMER INFORMATION RECEIVED, THIS UNIT WAS INSIDE A BOX OF ANOTHER BATCH, AND THE OTHER 4 UNITS INSIDE THE BOX WERE CORRECT. HOWEVER, THE BATCH OF THE PRODUCT BOX HAVE NOT BEEN RECEIVED. WITHOUT THIS INFORMATION, WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. THE CODE-BATCH RECEIVED WAS EXPIRED MORE THAN 4 YEARS AGO (EXPIRY DATE: 31.01.2015). AS NO BATCH NUMBER OF THE PRODUCT BOX INVOLVED IS RECEIVED, THE BATCH MANUFACTURING RECORD CANNOT BE REVIEWED. FINAL CONCLUSION: WITHOUT BATCH NUMBER OF THE PRODUCT BOX INVOLVED, 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 MORE INFORMATION IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012 REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K111959 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE AMPOULE EXPIRED. THE REPORTER INDICATED THAT AFTER OPENING A NEW BOX, OUT OF 5 PIECES, 1 PIECE WAS FOUND TO BE EXPIRED AND THE GLUE HAD HARDENED. NO OTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474728 HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050052 213031N1

    Patients

    Seq Age Sex Outcome Treatment
    1