BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE 0.5ML

    MDR report key: 8148239 · Received December 10, 2018

    Report

    Report Number
    3003639970-2018-00751
    Event Type
    Malfunction
    Date Received
    December 10, 2018
    Report Date
    January 21, 2019
    Manufacturer
    B. BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE RECEIVED TWO OPEN SAMPLES, THE AMPOULES RECEIVED HAVE BEEN OPTICALLY EVALUATED AND A DEFECT IN THE TIP OF THE AMPOULES WAS FOUND. THE TIP IS BENT. THE LEAKAGE OF THE GLUE OCCURS AT THIS POINT. A REVIEW OF THE BATCH MANUFACTURING RECORD REVEAL THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. TAKING INTO ACCOUNT THAT THE RESULTS OF THE SAMPLES RECEIVED DO NOT FULFIL B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF FAILURE IN THE SAMPLES RECEIVED. BASED ON THE CONCLUSION DERIVED FROM THE INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. ACCORDING TO OUR 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.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012. 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. PMA/510K: K111959. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRODUCT WAS FOUND TO BE LEAKING. THE ISSUE WAS NOTED UPON OPENING THE PACKAGE, AND THE HISTOACRYL AMPOULE WAS UNABLE TO BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988307 HISTOACRYL BLUE 0.5ML TISSUE ADHESIVES MPN B. BRAUN SURGICAL SA 1050044 217372N2

    Patients

    Seq Age Sex Outcome Treatment
    1