BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS C VIOLET 0 (3,5) 25M

    MDR report key: 3880691 · Received May 28, 2014

    Report

    Report Number
    2916714-2014-00395
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 28, 2014
    Manufacturer
    B. BRAUN SURGICAL S.A.
    Product Code
    NEW
    PMA / PMN Number
    K031216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 1 OPEN CASSETTE. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH. THERE ARE NO UNITS IN OEM STOCK. WE HAVE RECEIVED 1 OPEN CASSETTE, WITH THE OPENING DATE WRITTEN: (B)(6) 2014. THE RECEPTION DATE IS (B)(6) 2014, SO THE SUTURE WAS USED WITHIN 4 MONTH PERIOD AFTER OPENING. TESTED THE KNOT PULL TENSILE STRENGTH OF THE SAMPLE RECEIVED AND THE RESULTS FULFIL THE REQUIREMENTS OF THE OEM. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFIL OEM REQUIREMENTS. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTIONS ON PRODUCT: NOT APPLICABLE. CORRECTIVE/PREVENTATIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). SUTURE IS SNAPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314178 MONOPLUS C VIOLET 0 (3,5) 25M SYNTHETIC ABSORBABLE SUTURE NEW B. BRAUN SURGICAL S.A. F0024273 113231

    Patients

    Seq Age Sex Outcome Treatment
    1 Other