BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS VIOLET 0 (3.5) 70CM HR375 (M)

    MDR report key: 3695074 · Received February 7, 2014

    Report

    Report Number
    2916714-2014-00075
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Date of Event
    January 6, 2014
    Report Date
    February 3, 2014
    Manufacturer
    B. BRAUN SURGICAL S. A.
    Product Code
    NEW
    PMA / PMN Number
    K031216
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: SAMPLES RECEIVED: NONE. LIST OF BATCHES SUPPLIED TO THE HOSPITAL IN 2013: 112232, 112123, 112385, 113074, 113104, 113234, AND 113355. THERE ARE NO PREVIOUS COMPLAINTS OF THESE CODE/BATCHES. REVIEWED THE BATCH MANUFACTURING RECORD, THIS PRODUCT HAD A NORMAL PROCESS AND THE RESULTS DURING THE PROCESS FULFILL OEM REQUIREMENTS. ALL BATCHES INDICATED WERE TESTED BEFORE RELEASING THE PRODUCT AND FULFILLED OEM REQUIREMENTS. TENSILE TESTS ARE ALWAYS PERFORMED IN 100% OF MANUFACTURED BATCHES. REMARKS: THE COMPLAINT IS JUSTIFIED FOR ISOLATED DETACHED NEEDLE, BUT THE CONCLUSION IS NOT CORRESPONDING ACCORDING TO THE RESULTS OF THE IN PROCESS CONTROL WHEN THIS BATCH WAS MANUFACTURED. FINAL CONCLUSION: THE COMPLAINT IS NOT CORRESPONDING (NOT JUSTIFIED). ACTION ON PRODUCT: NOT APPLICABLE. CORRECTIVE/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78946 MONOPLUS VIOLET 0 (3.5) 70CM HR375 (M) NEW B. BRAUN SURGICAL S. A. C0024057

    Patients

    Seq Age Sex Outcome Treatment
    1 Other