BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 2/0 (3) 12X45CM

    MDR report key: 6139938 · Received December 1, 2016

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    Report

    Report Number
    2916714-2016-00992
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Report Date
    March 20, 2017
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    K031286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    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 H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: CZECH REPUBLIC. IT WAS REPORTED THAT THE PACKAGING OF THE INDIVIDUAL SLEEVES ARE NOT PROPERLY SEALED AND ONE OF THE PACKS IS EMPTY.

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 3 UNOPENED POUCHES AND 1 OPENED. ANALYSIS AND RESULTS: THERE ARE NO PREVIOUS COMPLAINTS OF THIS BATCH. MANUFACTURED AND DISTRIBUTED (B)(4) UNITS OF THIS BATCH. THERE ARE NO UNITS IN STOCK. RECEIVED THREE CLOSED SAMPLES AND ONE EMPTY SECOND PACK. THE PLASTIC FOIL SEALING OF SECOND PACK IN ALL UNITS RECEIVED IS INCOMPLETE (IT IS NOT PROPERLY SEALED). THE UPPER PART (1 CM APPROXIMATELY) IS MISSING. THE SECOND PACK PROTECTS THE INNER PACKAGE FROM EXTERNAL CONTAMINATION (MICROBIAL BARRIER). IN CASE THAT SECOND PACK IS OPEN/BROKEN, THE PRODUCT STERILITY IS COMPROMISED. THIS MISTAKE TOOK PLACE IN THE MANUFACTURING LINE, PROBABLY BECAUSE OF A DISPLACEMENT OF THE PLASTIC FILM WHEN MAKING THE SECOND PACK. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL B.BRAUN SURGICAL REQUIREMENTS. ACTIONS ON DISTRIBUTED PRODUCT OF THIS REFERENCE/BATCH: RECALL OF THE BATCH FROM THE MARKET. CORRECTIVE/PREVENTIVE ACTIONS: WE HAVE OPENED A CORRECTIVE/PREVENTIVE ACTION IN THE SYSTEM: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788975 SAFIL VIOLET 2/0 (3) 12X45CM SUTURES GAM B.BRAUN SURGICAL SA C1038666 116084V014

    Patients

    Seq Age Sex Outcome Treatment
    1 Other