BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE 0.5ML

    MDR report key: 7531856 · Received May 22, 2018

    Report

    Report Number
    3003639970-2018-00293
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    January 14, 2018
    Report Date
    May 21, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: EVALUATION: SAMPLES RECEIVED: NONE. ANALYSIS AND RESULTS: THERE IS A PREVIOUS COMPLAINT OF THIS CODE BATCH REGARDING THE SAME ISSUE. THE CASE WAS CLOSED AS CONFIRMED BY EVIDENCE OF THE SAMPLES RECEIVED. MANUFACTURED AND DISTRIBUTED INTO THE MARKET (B)(4) UNITS OF THIS CODE BATCH. THERE ARE NO UNITS IN STOCK IN THE WAREHOUSE. AS NO SAMPLES HAVE BEEN RECEIVED AND NO UNITS ARE AVAILABLE, ONLY REVIEWED THE BATCH MANUFACTURING RECORD AND THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL THE OEM REQUIREMENTS. FINAL CONCLUSION: WITHOUT SAMPLES WE ARE NOT IN POSITION OF STUDYING IF THE AFFECTED PRODUCT DOES NOT FULFIL THE SPECIFICATIONS. IN CONSEQUENCE, A PROPER ANALYSIS CANNOT BE DONE AND THE CASE IS NOT CONFIRMED DUE TO LACK OF EVIDENCE. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. 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: CHINA. IT WAS REPORTED THAT BEFORE THE PACKAGE WAS USED IT SHOWED THAT THERE WAS LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374863 HISTOACRYL BLUE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050044 216224N2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other