BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE 0.5ML

    MDR report key: 6540479 · Received May 3, 2017

    Report

    Report Number
    3003639970-2017-00223
    Event Type
    Malfunction
    Date Received
    May 3, 2017
    Date of Event
    April 6, 2017
    Report Date
    June 20, 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. AESCULAP INC. (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: (B)(6). IT WAS REPORTED THAT THE GLUE LEAKED IN THE ORIGINAL PACKAGE.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 1 OPEN POUCH. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS BATCH OF WHICH (B)(4) UNITS OF THIS BATCH WERE MANUFACTURED AND DISTRIBUTED IN THE MARKET, THERE ARE NO UNITS IN B. BRAUN SURGICAL STOCK. WE HAVE RECEIVED 1 OPEN POUCH WITH LEAKAGE SIGNS INSIDE. THE AMPOULE HAS BEEN CHECKED THAT THE SEALING BAR (YELLOW BAR AT THE BOTTOM OF THE AMPOULE IS WRONGLY SEALED AND THERE IS LEAKAGE). THE HISTOACRYL MACHINE FOR FILLING AMPOULES AND PACKAGING THEM INTO THE POUCHES WAS DESIGNED TO DETECT EVERY EMPTY POUCH AND NON CONFORMING AMPOULE. THE DEFECTIVE PRODUCTS WERE DISCARDED IN A SEPARATE BIN. IN THIS CASE, MOST PROBABLY THERE HAD BEEN TOO MANY NON CONFORMING POUCHES CAUSING AN OVERFLOW OF THE BIN. THE DESIGN OF THE BIN AT THAT TIME ALLOWED THAT THE FAULTY POUCHES COULD HAVE FALLEN FROM THE REJECT BIN INTO THE CONVEYOR BELT FOR THE CORRECT POUCHES. IN APRIL 2016 A CORRECTIVE ACTION IN THE REJECT BIN PUT AN OUTLET TO THE OPPOSITE SIDE TO THE CONVEYOR BELT. IN CONSEQUENCE, FROM THAT MOMENT THIS DEFECT SHOULD NOT OCCUR AGAIN. THE COMPLAINED BATCH WAS MANUFACTURED PREVIOUS TO THE CORRECTIVE ACTION IMPLEMENTED. REVIEWED THE BATCH MANUFACTURING RECORD, THERE IS A DEVIATION BUT NOT RELATED TO THIS COMPLAINT (DYE CONTENT MEASUREMENT).THE PRODUCT FULFILLED B. BRAUN SURGICAL REQUIREMENTS. ACTIONS ON DISTRIBUTED PRODUCT OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. CORRECTIVE/PREVENTIVE ACTIONS: CORRECTIVE ACTION ALREADY IMPLEMENTED CHANGED THE DESIGN OF THE REJECT BIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322323 HISTOACRYL BLUE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050044 215485 N1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other