BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE 0.5ML

    MDR report key: 5441990 · Received February 17, 2016

    Report

    Report Number
    2916714-2016-00070
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Report Date
    May 31, 2016
    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 · 1

    MEDWATCH REPORTS FILED IN REGARDS TO HISTOACRYL (PRODUCT NUMBERS 1050044 AND 1050060). REPORTED ISSUES: GLUE CAN'T FLOW FROM AMPOULE, SOMETHING WHIT AFTER POLYMERIZATION, AMPOULE LEAKAGE INSIDE THE POUCH, COMPLAINT REPORTS WERE RECEIVED FROM (B)(6) FROM SEPT 2015 TO MARCH 2016. COMPLAINT REPORTS WERE REVIEWED AND IT WAS FOUND THAT DESPITE THE DIFFERING CUSTOMER DESCRIPTION, MOST OF THE COMPLAINED SAMPLES SHARED THE SAME KIND OF DEFECT. MANY OF THE AMPOULES SHOWED A CLEAR BENDING IN THE CANNULA-TIP TRANSITION AND BENDING ALWAYS OCCURRED IN THE THINNEST WALL AREA OF THIS TRANSITION. PRODUCTION DATA RECORDS, STORAGE RECORDS AND TRANSPORTATION RECORDS WERE REVIEWED FOR ALL AFFECTED BATCHES AND NO INCIDENCES WERE FOUND. THE LOTS OF RAW MATERIAL USED FOR THE PRODUCTION OF THE AMPOULES WERE IDENTIFIED AND ANALYZED. THE OBSERVED DEVIATIONS (COMPLAINTS) WERE NOT LIMITED TO A SINGLE BATCH OF RAW MATERIAL, NOR WERE THEY LIMITED TO A SINGLE CAVITY OF THE AMPOULE MOLD. THE SUPPLIER OF THE AMPOULE WAS ASKED FOR INCIDENCES OR CHANGES DURING PRODUCTION OF THE COMPLAINED LOT NUMBERS AND NO INCIDENCES WERE FOUND, NO CHANGES WERE REPORTED. DESPITE THE DIFFERENT STUDIES PERFORMED, THE ROOT CAUSE OF PRODUCT COMPLAINTS RECEIVED FROM CHINA REMAINS UNCLEAR: PRODUCTION, STORAGE AND TRANSPORTATION DATA RECORDS OF AFFECTED BATCHES WERE REVIEWED NO INCIDENCES WERE FOUND. LOTS OF RAW MATERIAL (AMPOULE) USED FOR PRODUCTION OF AFFECTED BATCHES OF FINISHED PRODUCT WERE IDENTIFIED AND DEEPLY ANALYZED NO INCIDENCES WERE FOUND. FURTHERMORE, IT COULD NOT BE CONCLUDED THAT PRODUCT COMPLAINTS COME FROM A WELL IDENTIFIED RAW MATERIAL BATCH OF AMPOULES NOR FROM A DEFINED CAVITY FROM THE MOULDING PROCESS. IT COULD NOT BE DEMONSTRATED THAT A MINIMUM WALL THICKNESS AT THE CANNULA-TIP TRANSITION COULD EXPLAIN OBSERVED DEFECTS. IN THIS SENSE: WALL THICKNESS AT THE CANNULA-TIP TRANSITION HAS SHOWN TO BE SIGNIFICANTLY LOWER IN CAVITY 4 THAN CAVITY 3. PRODUCT COMPLAINTS COMING FROM CHINA ARE NOT LIMITED TO ONE SINGLE CAVITY. FURTHERMORE, IT IS THOUGHT THAT IF THIS WAS IN FACT THE ROOT CAUSE OF OBSERVED INCIDENCES, THE PROBLEM WOULD NOT BE LIMITED TO CHINA BUT OTHER COUNTRIES AND/OR BATCHES WOULD BE AFFECTED. SEVERAL STRESS STUDIES WERE PERFORMED WITH THE AIM OF PROVOKING OBSERVED DEFECTS NONE OF THEM LEAD TO SPECIMENS SHOWING COMPLAINED DEFECTS. RELATED TO THE EXTENSION ANALYSIS, THERE ARE SOME RELEVANT DATA THAT ARE TO BE TAKEN INTO ACCOUNT: THE PERCENTAGE OF UNITS DISTRIBUTION TO CHINA OVER THE TOTAL NUMBER OF RELEASED AMPOULES WAS BETWEEN ABOUT 25-60%(AVERAGE 40%). THE PERCENTAGE OF COMPLAINED UNITS (CONSIDERING THE COMPLETE REFERENCE/BATCH) OVER THE TOTAL NUMBER OF AMPOULES DISTRIBUTED TO CHINA WAS ABOUT 25%. IN CONCLUSION: THE INVESTIGATION ABOUT HANDLING AND LOCAL TRANSPORTATION BY (B)(6) SUBSIDIARY IS ON GOING.

    Additional Manufacturer Narrative · 1

    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. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). GLUE CAN'T FLOW FROM AMPOULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97217 HISTOACRYL BLUE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050044 215081N2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other