BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL BLUE 0.5ML

    MDR report key: 8404642 · Received March 8, 2019

    Report

    Report Number
    3003639970-2019-00290
    Event Type
    Malfunction
    Date Received
    March 8, 2019
    Report Date
    May 1, 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. MANUFACTURING SITE EVALUATION: INVESTIGATION - WE RECEIVED 1 OPEN POUCH THAT CONTAINS AN UNOPENED AMPOULE. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. THERE ARE NO UNITS IN STOCK. WE HAVE RECEIVED AN UNOPENED AMPOULE WITH SIGNS OF LEAKAGE. HOWEVER, THIS PRODUCT EXPIRED ON 31JAN2019 AND THE COMPLAINT RECEIVED WAS AFTER THIS DATE (21FEB2019). THEREFORE, AS THIS PRODUCT HAS ALREADY EXPIRED A PROPER ANALYSIS CANNOT BE PERFORMED. WE HAVE REVIEWED THE BATCH MANUFACTURING RECORDS OF THIS PRODUCT AND THERE ARE NO INCIDENCES RELATED TO THIS ISSUE. FINAL CONCLUSION - PRODUCT ALREADY EXPIRED WHEN COMPLAINT WAS RECEIVED.

    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, (B)(4) MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. 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 THERE WAS AN ISSUE WITH A HISTOACRYL AMPOULE. AFTER THE PACKAGE WAS OPENED, LEAKAGE WAS FOUND. THE PRODUCT WAS NOT USED ON A PATIENT. ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198175 HISTOACRYL BLUE 0.5ML TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1050044 217063N1

    Patients

    Seq Age Sex Outcome Treatment
    1