BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPRAMID BLACK 4/0 (1.5) 45CM HS21

    MDR report key: 6358889 · Received February 24, 2017

    Report

    Report Number
    3003639970-2017-00071
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Report Date
    March 22, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE THAT IS REGISTERED WITHIN THE U.S. AESCULAP INC. (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: (B)(6). IT WAS REPORTED THAT THE PACKAGE WAS LABELED (B)(4) BUT THE INSIDE PRODUCT WAS LABELED (B)(4). THE WRONG PRODUCT WAS INSIDE THE BOX.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 1 UNOPENED BOX (36 POUCHES). ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS BATCH. MANUFACTURED AND DISTRIBUTED IN THE MARKET (B)(4) UNITS OF THIS BATCH. THERE ARE NO UNITS IN STOCK. RECEIVED 1 CLOSED BOX. THE BOX LABEL AND PRODUCT IS SUPRAMID BLACK 4/0 (1.5) 45CM HS21 (CODE C0712256 AND BATCH 616466) BUT THE BOX THAT CONTAINS THE PRODUCT IS A DAFILON PRE-PRINTED BOX. THIS MISTAKE TOOK PLACE IN PRODUCTION AREA WHEN PACKING THE PRODUCT INTO THE BOXES, THE OPERATOR TOOK A DAFILON BOX INSTEAD OF A SUPRAMID'S. CORRECTIVE/PREVENTIVE ACTIONS: THIS COMPLAINT IS RECORDED FOR TRENDING ANALYSIS TO ASSESS IF ACTIONS ARE NEEDED IN THE FUTURE. NEVERTHELESS, THE STORAGE LOCATIONS OF THE PRE-PRINTED BOXES WILL BE REARRANGING TO AVOID THIS DEFECT AND BIN IDENTIFICATION LABELING WILL BE CHANGED TO IMPROVE VISIBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138653 SUPRAMID BLACK 4/0 (1.5) 45CM HS21 SUTURES GAR B.BRAUN SURGICAL SA C0712256 616466V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other