BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML

    MDR report key: 7522944 · Received May 17, 2018

    Report

    Report Number
    3003639970-2018-00274
    Event Type
    Malfunction
    Date Received
    May 17, 2018
    Date of Event
    September 15, 2017
    Report Date
    May 17, 2018
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 IS ONE PREVIOUS COMPLAINT OF THE SAME REFERENCE-BATCH REGARDING OTHER ISSUE. MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE BATCH. THERE ARE NO UNITS IN STOCK. REVIEWED THE BATCH MANUFACTURING RECORD, THERE IS A DEVIATION BUT NOT RELATED TO THE PRODUCT COMPLAINT. RECEIVED ONE OPEN SAMPLE. THE GLUE IS POLYMERIZED INSIDE THE AMPOULE. CHECKED THE AMPOULE OF THIS OPEN SAMPLE RECEIVED AND IT WAS FOUND THAT THE TIP OF THE AMPOULE IS ALREADY CUT AND THERE ARE NO DEFECTS AT THE SEALING BAR OF THE AMPOULE (YELLOW BAR AT THE BOTTOM OF THE AMPOULE). HOWEVER, WITHOUT ANY CLOSED SAMPLE A PROPER ANALYSIS CAN NOT BE PERFORMED. REMARKS: ACCORDING THE INSTRUCTIONS FOR USE, HISTOACRYL SHOULD BE STORED AT AMBIENT TEMPERATURE BELOW 22ºC. THE AMPOULE CONTAINING THE ADHESIVE SHOULD ONLY BE REMOVED FROM THE ALUMINIUM POUCH IMMEDIATELY PRIOR TO APPLICATION. FINAL CONCLUSION: IN SPITE OF RECEIVING A DEFECTIVE SAMPLE, WITHOUT CLOSED SAMPLES A SUITABLE ANALYSIS CANNOT BE PERFORMED. NEVERTHELESS, NOTE OF THIS INCIDENT WAS TAKEN AND IF ANY CLOSED SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. 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: COLOMBIA. IT WAS REPORTED THAT WHEN OPENING THE ENVELOPE OF HISTOACRYL THE CONTENTS WERE DRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364155 HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050052 216051N3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other