BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPRAMID WHITE 5/0 (1) 45CM 2XVLM8 (M)

    MDR report key: 6332329 · Received February 15, 2017

    Report

    Report Number
    3003639970-2017-00067
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    January 9, 2017
    Report Date
    March 22, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    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, (B)(4) 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 THERE WAS A MIX UP OF THE SUTURES. THE AFFECTED PRODUCT IS G0698642 AND G1048620.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 1 UNOPENED BOX (12 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 ONE CLOSED BOX WHICH CONTAINS 12 POUCHES. ALL UNITS OF THE BOX ARE OF THE REFERENCE-BATCH 0698642-116402 (SUPRAMID WHITE 5/0 (1) 45 CM 2XVLM8). THE PRE-PRINTED BOX IS OF SUPRAMID, BUT THE BOX LABEL CORRESPONDS TO THE REFERENCE-BATCH G1048620-116402 (SAFIL VIOLET 8/0 (0.4) 30CM DLM6S). PRODUCTS TRACEABILITY HAS BEEN CHECKED AND IT HAS BEEN DETERMINED THAT THIS MIX-UP TOOK PLACE AT THE MOMENT OF PREPARING THE SHIPMENT IN THE WAREHOUSE. ONE BOX OF THE REFERENCE G1048620 AND 1 BOX OF THE REFERENCE G0698642 WERE PREPARED AT THE SAME TIME. CORRECTIVE/PREVENTIVE ACTIONS: ACCORDING TO 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
    116208 SUPRAMID WHITE 5/0 (1) 45CM 2XVLM8 (M) SUTURES GAM B.BRAUN SURGICAL SA G0698642 116402V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other