BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPLUS VIOLET 3/0 (2) 70CM HR26 (M)

    MDR report key: 3880681 · Received May 28, 2014

    Report

    Report Number
    2916714-2014-00398
    Event Type
    Malfunction
    Date Received
    May 28, 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 Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES RECEIVED: 1 OPEN POUCH. THERE ARE NO PREVIOUS COMPLAINTS OF THIS CODE/BATCH, NO UNITS IN OEM STOCK. RECEIVED 1 OPEN SAMPLE WITH THE NEEDLE DETACHED FROM THE THREAD (NEEDLE WAS USED - HAS THE RESTS OF BLOOD). WITHOUT ANY CLOSED SAMPLE WE CANNOT CARRY OUT A COMPLETE ANALYSIS. NEEDLE ATTACHMENT RESULTS CONDUCTED ON SAMPLES BEFORE RELEASING THE PRODUCT FULFILLED OEM REQUIREMENTS. 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/PREVENTIVE ACTIONS: NOT APPLICABLE.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT:(B)(6). ONE UNIT WAS FAULTY, THE NEEDLE WAS NOT ATTACHED TO THE THREAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313860 MONOPLUS VIOLET 3/0 (2) 70CM HR26 (M) SYNTHETIC ABSORBABLE SUTURE NEW B. BRAUN SURGICAL S.A. G0024025 114043

    Patients

    Seq Age Sex Outcome Treatment
    1 Other