BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE WAX 24X2.5G

    MDR report key: 8587346 · Received May 7, 2019

    Report

    Report Number
    3003639970-2019-00391
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Report Date
    May 23, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MTJ
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. INVESTIGATION: SAMPLES RECEIVED: ONE CLOSED AND EMPTY UNIT. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THE SAME CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED ONE CLOSED AND EMPTY SAMPLE. THE PRIMARY AND SECONDARY PACKAGING ARE INTACT. THE PRIMARY PACK WAS MARKED AS EMPTY DURING PRODUCTION BUT IT WAS NOT DISCARDED. WE ASSUME A HUMAN ERROR OF THE OPERATOR THAT DID NOT DISCARD THE DEFECTIVE UNIT. AS THERE ARE NO PREVIOUS COMPLAINTS, WE ASSUME THAT THIS IS AN ISOLATED UNIT. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND NO DEVIATIONS HAVE BEEN FOUND. REMARKS: WE WILL INFORM THE PERSONNEL INVOLVED ABOUT THIS INCIDENCE. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE RESULT OF SAMPLE RECEIVED DOES NOT FULFIL THE B. BRAUN SURGICAL SPECIFICATIONS, WE CONCLUDE THAT THE COMPLAINT IS CONFIRMED BY EVIDENCE OF 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. YOU WILL RECEIVE A CREDIT NOTE FOR ONE BOX OF PRODUCT AS COMPENSATION. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). 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. K000021 IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE REPORTER INDICATED THAT THERE WAS NO PRODUCT INSIDE THE PACKAGE. NO OTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382239 BONE WAX 24X2.5G HAEMOSTYPTICS, PROPHYLAXIS OF MTJ B.BRAUN SURGICAL SA 1029754 218504

    Patients

    Seq Age Sex Outcome Treatment
    1