BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE 0.5ML

    MDR report key: 6029708 · Received October 14, 2016

    Report

    Report Number
    2916714-2016-00854
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 16, 2016
    Report Date
    March 21, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE THAT IS REGISTERED WITHIN THE U.S. (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: VIETNAM. IT IS REPORTED BY THE CUSTOMER THAT THE HISTOACRYL (1050044) TUBE HAS BEEN SOLIDIFIED, HARD AND THE COLOR HAS CHANGED.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: NO SAMPLES AVAILABLE. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS BATCH. MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4)UNITS OF THIS BATCH. THERE ARE NO UNITS IN STOCK. WITHOUT SAMPLES WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. REMARKS: ACCORDING TO 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: 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. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYSE IT. PLEASE NOTE THAT WHEN NO SAMPLES ARE RECEIVED OUR ANALYSIS IS VERY LIMITED. 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. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682387 HISTOACRYL BLUE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050044 215105N1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other