BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML

    MDR report key: 8769082 · Received July 8, 2019

    Report

    Report Number
    3003639970-2019-00524
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    June 11, 2019
    Report Date
    August 26, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLES RECEIVED: 1 OPEN POUCH. ANALYSIS AND RESULTS: THERE IS ONE PREVIOUS COMPLAINT OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED OPEN SAMPLE. THE AMPOULE RECEIVED FROM THE OPEN POUCH HAS BEEN OPTICALLY EVALUATED AND A DEFECT IN THE TIP OF THE AMPOULE HAS BEEN FOUND. THE LEAKAGE OF THE GLUE OCCURS AT THIS POINT. WE HAVE CONDUCTED A REVIEW OF THE BATCH MANUFACTURING RECORD OF THIS PRODUCT AND NO DEVIATIONS HAVE BEEN FOUND. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULTS OF THE SAMPLE RECEIVED DO NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF FAILURE IN THE SAMPLE RECEIVED. 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. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    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 OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K111959. WHEN ADDITIONAL INFORMATION HAS BEEN RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CONTENTS OF THE PACKAGE IS DAMAGE. THE REPORTER INDICATED THAT WHEN THE PACKAGE WAS OPENED THE TUBE (AMPOULE TIP) WAS FOUND DAMAGED. THE EVENT WAS DISCOVERED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561256 HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050052 217381N2

    Patients

    Seq Age Sex Outcome Treatment
    1