BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE WAX 24X2.5G

    MDR report key: 9258393 · Received October 30, 2019

    Report

    Report Number
    3003639970-2019-00742
    Event Type
    Malfunction
    Date Received
    October 30, 2019
    Date of Event
    October 11, 2019
    Report Date
    December 15, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MTJ
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SAMPLES RECEIVED: 1 UNOPENED POUCH. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WE MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4). THERE ARE NO UNITS IN BBS STOCK. WE HAVE RECEIVED A CLOSED POUCH WITHOUT PRINTED LABEL IN IT. THIS DEFECT WAS CAUSED IN THE PRODUCTION AREA. AS NO OTHER COMPLAINTS HAVE BEEN RECEIVED OF THIS CODE BATCH WE CONSIDER THAT THIS UNIT IS AN ISOLATED AND ACCIDENTAL DEFECT THAT WAS NOT DETECTED AT THE MOMENT OF PACKAGING THE PRODUCT. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: TAKING INTO ACCOUNT THAT THE 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. NO CORRECTIVE/PREVENTIVE ACTIONS NEEDED.

    Additional Manufacturer Narrative · 1

    PMA/510K: 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 BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE IS NO LABEL ON THE BONE WAX. THE REPORTER INDICATED THE LABEL IS MISSING ON THE PACKAGING. THE EVENT OCCURRED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050869 BONE WAX 24X2.5G HAEMOSTYPTICS, PROPHYLAXIS OF MTJ B.BRAUN SURGICAL SA 1029754 218482

    Patients

    Seq Age Sex Outcome Treatment
    1