BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAFILON BLUE 4/0 (1.5) 75CM DS19

    MDR report key: 8646964 · Received May 28, 2019

    Report

    Report Number
    3003639970-2019-00424
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Report Date
    May 28, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAR
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. K990090. SAMPLES RECEIVED: 1 OPEN POUCH. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE-BATCH. WE MANUFACTURED AND DISTRIBUTED IN THE MARKET 12,744 UNITS OF THIS CODE-BATCH. THERE ARE NO UNITS IN OUR STOCK. WE HAVE RECEIVED ONE OPEN AND UNUSED SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD, AND THE THREAD IS STILL WOUND ON THE PACK. HOWEVER, WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT AN ANALYSIS IN ORDER TO TAKE A DECISION. A REVIEW OF THE BATCH MANUFACTURING RECORD SHOWS THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL USP/EP AND B. BRAUN SURGICAL REQUIREMENTS. FINAL CONCLUSION: IN SPITE OF RECEIVING A DEFECTIVE SAMPLE, WITHOUT CLOSED SAMPLES A SUITABLE ANALYSIS CANNOT BE PERFORMED. NEVERTHELESS, WE TAKE NOTE OF THIS INCIDENCE AND IF ANY CLOSED SAMPLE IS RECEIVED IN THE FUTURE, WE WILL RE-OPEN THE CASE AND ANALYZE IT. ACTIONS ON PRODUCT DISTRIBUTED OF THIS REFERENCE/BATCH: BASED ON THE CONCLUSION DERIVED FROM INVESTIGATION, IT IS NOT REQUIRED TO MAKE ACTIONS IN DISTRIBUTED PRODUCT. ANYWAY, YOU WILL RECEIVE A CREDIT NOTE FOR ONE BOX OF PRODUCT AS A QUALITY COURTESY. NO CORRECTIVE/PREVENTIVE ACTIONS ARE NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE NEEDLE DETACHED. THE REPORTER INDICATED THAT THE NEEDLE WAS DETACHED FROM THE THREAD IN THE ORIGINAL PACKET. THERE WAS NO REPORTED PATIENT HARM AND NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439130 DAFILON BLUE 4/0 (1.5) 75CM DS19 OTHER SUTURE GAR B.BRAUN SURGICAL SA C0935204 618257

    Patients

    Seq Age Sex Outcome Treatment
    1