BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    [RE,O;EME 0 (3.5) 75CM HR26 9M)

    MDR report key: 4351225 · Received December 12, 2014

    Report

    Report Number
    2916714-2014-00947
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    October 21, 2014
    Report Date
    December 5, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    GAW
    PMA / PMN Number
    K980703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNITED STATES REPORTING AGENT NOTIFIED ON: (B)(4) 2014. MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: 20 UNOPENED AND 3 OPEN RACEPACKS. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE BATCH. THERE ARE NO UNITS IN OEM STOCK. RECEIVED THREE OPEN SAMPLES, TWO OF THEM WITH THE NEEDLE DETACHED FROM THE THREAD AND THREAD STILL WOUND ON THE PACK IN BOTH SAMPLES. THE OTHER OPEN SAMPLE RECEIVED HAS THE NEEDLE CONNECTED TO THE THREAD. TESTED THE NEEDLE ATTACHMENT OF THE SAMPLES RECEIVED AND THE RESULTS FULFILL THE REQUIREMENTS OF THE OEM. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTIONS ON PRODUCT: NOT APPLICABLE. CORRECTIVE/PREVENTIVE ACTIONS:

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). THREAD DETACHED FROM NEEDLE EASILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818753 [RE,O;EME 0 (3.5) 75CM HR26 9M) CARDIAC SUTURE GAW B. BRAUN SURGICAL S.A. C2090043 113211V004

    Patients

    Seq Age Sex Outcome Treatment
    1 Other