BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICRON G/W 2/0 (3) 4X75 2XHRC17 (M)

    MDR report key: 3960940 · Received May 23, 2014

    Report

    Report Number
    2916714-2014-00375
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    November 11, 2013
    Report Date
    May 23, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAT
    PMA / PMN Number
    K012201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON (B)(6) 2014. MANUFACTURING SITE EVALUATION: SAMPLES REC'D: NO SAMPLES HAVE BEEN REC'D FROM THE CUSTOMER AND THERE ARE NO UNITS IN OEM STOCK. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. (B)(4) UNITS OF THIS CODE BATCH WERE MANUFACTURED AND DISTRIBUTED TO CUSTOMERS IN TWO COUNTRIES. AS WE HAVE NOT REC'D SAMPLES FROM CUSTOMER AND THERE ARE NO UNITS IN STOCK A PROPER ANALYSIS CANNOT BE PERFORMED. REVIEWED THE BATCH MANUFACTURING RECORD AND THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL OEM REQUIREMENTS. THE RESULTS OF NEEDLE ATTACHMENT STRENGTH DURING THE PROCESS WERE WITHIN OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTIONS ON PRODUCT: NOT APPLICABLE. CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). OEM REC'D A REPORT FROM (B)(6) REGARDING 2 CASES FROM ONE CUSTOMER. TWO DIFFERENT HEART VALVE OPERATIONS. THE FIRST ONE THE SUTURES BROKE. DURING THE SECOND ONE THE NEEDLE DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307363 PREMICRON G/W 2/0 (3) 4X75 2XHRC17 (M) CARDIAC SUTURE GAT B. BRAUN SURGICAL S.A. M0027921 113235V070

    Patients

    Seq Age Sex Outcome Treatment
    1 Other