BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAFILON BLUE 4/0 (1.5) 45CM DS16

    MDR report key: 6083835 · Received November 7, 2016

    Report

    Report Number
    2916714-2016-00912
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    September 10, 2016
    Report Date
    February 2, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER). EXEMPTION NUMBER: E2014012. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: SOUTH KOREA. IT WAS REPORTED THAT THERE WAS INCORRECT PRODUCT (0932078) INSIDE OF THE BOX PRINTED (B0932132).

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: NONE, PICTURES. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH OF WHICH WERE MANUFACTURED (B)(4) UNITS. THERE ARE (B)(4) UNITS IN STOCK. RECEIVED ONE PICTURE WHICH SHOWS THAT ALL UNITS OF ONE BOX LABELED AS B0932131 (DAFILON 4/0 45CM DS12) WITH BATCH 616162 HAVE INSIDE THE BOX THE REFERENCE B0932078 (DAFILON 5/0 45CM DS12) WITH BATCH 616162. PRODUCTS TRACEABILITY HAS BEEN CHECKED AND IT HAS BEEN DETERMINED THAT THIS MIX-UP TOOK PLACE IN THE WAREHOUSE IN THE PACKAGING AREA. BOTH PRODUCTS WERE PACKED IN THE SAME LINE AND SAME DAY. 42 BOXES OF THE REFERENCE B0932078 AND 45 BOXES OF THE REFERENCE B0932132 WERE PREPARED AT THE SAME MOMENT, THE NUMBER OF BOXES WITH THE MIX-UP CANNOT BE DETERMINED. FINAL CONCLUSION: THE COMPLAINT IS JUSTIFIED. TAKING INTO ACCOUNT THAT THE BOX CONTAINS WRONG PRODUCT INSIDE. FINAL CONCLUSION: 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734784 DAFILON BLUE 4/0 (1.5) 45CM DS16 SUTURES GAR B.BRAUN SURGICAL SA B0932132 616162

    Patients

    Seq Age Sex Outcome Treatment
    1 Other