BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HISTOACRYL BLUE 0.5ML

    MDR report key: 9717663 · Received February 17, 2020

    Report

    Report Number
    3003639970-2020-00094
    Event Type
    Injury
    Date Received
    February 17, 2020
    Date of Event
    January 27, 2020
    Report Date
    April 13, 2020
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES RECEIVED: (B)(4) OPEN POUCH. ANALYSIS AND RESULTS: THERE IS A PREVIOUS COMPLAINT OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN STOCK IN B. BRAUN SURGICAL'S WAREHOUSE. WE HAVE RECEIVED ONE OPEN POUCH THAT CONTAINS AN UNOPENED AMPOULE. THE AMPOULE HAS BEEN OPTICALLY EVALUATED AND A DEFECT IN THE SEALING BAR OF THE AMPOULE (YELLOW BAR AT THE BOTTOM OF THE AMPOULE) WAS 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 RELATED TO THIS ISSUE 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. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO OUR INTERNAL PROCEDURES, WE HAVE OPENED A CAPA.

    Additional Manufacturer Narrative · 1

    PMA/510K: 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AMPOULE LEAKAGE OCCURRED. THE REPORTER INDICATED WHEN OPENING THE PACKAGE, THE LEAKAGE FROM THE AMPULE WAS ALREADY CAUSED, THEREFORE THE PRODUCT WAS NOT ABLE TO BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181450 HISTOACRYL BLUE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050044 218445N1

    Patients

    Seq Age Sex Outcome Treatment
    1