BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE 0.5ML

    MDR report key: 8095994 · Received November 21, 2018

    Report

    Report Number
    3003639970-2018-00725
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    October 22, 2018
    Report Date
    January 7, 2019
    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

    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: K111959. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE HISTORY RECORD (DHR): INITIAL EVALUATION WITHOUT SAMPLE- THE DEVICE HISTORY RECORD HAS BEEN REVIEWED. THE DEVICE HISTORY RECORD WAS RELEASED WITH TWO DEVIATIONS: VACUUM TREATMENT WITH ERROR COMMUNICATION BETWEEN THE MACHINE AND THE MES. MICROBIOLOGICAL DEVIATION. BOTH ABOVE DEVIATIONS ARE NOT RELEVANT TO THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    THERE IS ONE PREVIOUS COMPLAINT OF THE SAME CODE-BATCH REGARDING AMPOULE LEAKAGE. WE HAVE RECEIVED AN OPEN POUCH WITH AN EMPTY AND UNSEALED AMPOULE AS CAN BE SEEN IN THE ENCLOSED PICTURES. THE BATCH MANUFACTURING RECORD OF THIS PRODUCT HAS BEEN REVIEWED AND THERE ARE NO DEVIATIONS REGARDING THIS ISSUE. THE MACHINE FOR FILLING HISTOACRYL AMPOULES AND PACKAGING THEM INTO THE POUCHES WAS DESIGNED TO DETECT EVERY POUCH AND NON-CONFORMING AMPOULE AND SORT THEM OUT. ALTHOUGH THE REVIEW OF THE BATCH MANUFACTURING RECORD CONFIRM THAT NO INCIDENCES REGARDING THIS ISSUE WERE FOUND DURING THE PRODUCTION OF THIS CODE-BATCH, WE ASSUME A TEMPORARY FAILURE OF THE FILLING AND PACKAGING MACHINE AS NO OTHER CUSTOMER COMPLAINTS RELATED TO THIS ISSUE HAVE BEEN RECEIVED OF THIS CODE-BATCH. THE MANUFACTURER OF THE MACHINE IS LOOKING INTO THIS ISSUE AND WILL PROPOSE SOME MEASURES IN ORDER TO AVOID THAT THIS ISSUE HAPPENS AGAIN. WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF THE SAMPLE 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 A PRODUCT ISSUE WITH HISTOACRYL. THE MALFUNCTION WAS NOTED PRIOR TO PATIENT USE. WHEN OPENING THE PACKAGE, AN EMPTY AMPULE WAS FOUND INSIDE. IT SEEMED THAT THE BOTTOM WAS MISSING OR CUT OFF. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934364 HISTOACRYL BLUE 0.5ML TISSUE ADHESIVES MPN B. BRAUN SURGICAL SA 1050044 217421N2

    Patients

    Seq Age Sex Outcome Treatment
    1