BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE 0.5ML

    MDR report key: 6089822 · Received November 9, 2016

    Report

    Report Number
    2916714-2016-00925
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 13, 2016
    Report Date
    March 17, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    NARRATIVE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 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 H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: CHINA. THE TUBE OF THE AMPOULES IS FROZEN. THE GLUE CAN NOT FLOW, THE TIP IS BLOCKED. THE DEVICE CAN NOT BE USED. THE MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 2916714-2016-00920, 2916714-2016-00919, 2916714-2016-00921, 2916714-2016-00922, 2916714-2016-00923, 2916714-2016-00924, 2916714-2016-00925, 2916714-2016-00926.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: NONE. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS BATCH. MANUFACTURED AND DISTRIBUTED 4,245 UNITS. THE PRODUCT REFERENCE INFORMED (1050044) IS NOT CORRECT, NO ORDER WAS PRODUCED WITH THE COMBINATION 1050044 AND BATCH 214483N2. THERE IS AN ORDER WITH ITEM NUMBER 10050052 AND BATCH 214483N2. WE WILL ASSUME THAT THIS IS THE REFERENCE AND BATCH AFFECTED. AGEING STUDIES WERE PERFORMED WITH THE PURPOSE OF PROVOKING THE COMPLAINED DEFECT AND STUDY THE INFLUENCE OF ENVIRONMENTAL CONDITIONS IN ITS APPARITION. -AMPOULES WERE STRESSED FOR 9 DAYS AT 40ºC AND 30 % RH. AFTER 4 DAYS OF EXPOSURE, THE STRESS CONDITIONS CAUSED THE APPARITION OF SOME POLYMERIZATION NUCLEI ALONG THE CANNULA IN THE AMPOULES. HOWEVER, THE LIQUID GLUE COULD STILL PASS THROUGH THE CANNULA, THAT WAS NOT OBSTRUCTED. AFTER 9 DAYS OF EXPOSURE, THE POLYMERIZATION NUCLEI OBSERVED CAUSED THE OBSTRUCTION OF THE CANNULA. IN CONCLUSION, THE ENVIRONMENTAL CONDITIONS INFLUENCE THE APPARITION OF THE POLYMERIZATION NUCLEI ALONG THE CANNULA. A TEMPERATURE OF 40ºC CAUSED THE FORMATION OF POLYMERIZATION NUCLEI ALONG THE CANNULA AND THE OBSTRUCTION OF THE CANNULA AFTER 9 DAYS OF EXPOSURE. THEREFORE, AND 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: 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
    742154 HISTOACRYL BLUE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050044 214483N2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other