BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML

    MDR report key: 8316865 · Received February 7, 2019

    Report

    Report Number
    3003639970-2019-00086
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Report Date
    February 7, 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

    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 G5: 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 MANUFACTURING SITE EVALUATION: WE HAVE RECEIVED TWO OPEN SAMPLES, THE AMPOULES RECEIVED HAVE BEEN OPTICALLY EVALUATED AND A DEFECT IN THE TIP OF THE AMPOULES WAS FOUND. TIP IS BENT. THE LEAKAGE OF THE GLUE OCCURED AT THIS POINT. REVIEW OF THE BATCH MANUFACTURING RECORD SHOWED 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 DOES 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH 2 HISTOACRYL AMPOULES. AFTER OPENING THE PACKAGES, IT WAS DISCOVERED THAT LIQUID WAS LEAKING FROM THE AMPOULES. THE PRODUCTS WERE NOT USED ON A PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. ASSOCIATED MEDWATCHES: 3003639970-2018-00626.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108814 HISTOACRYL BLUE TISSUE ADHESIVE 0.5ML TISSUE ADHESIVES MPN B BRAUN SURGICAL SA 1050052 217332N2

    Patients

    Seq Age Sex Outcome Treatment
    1