BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT AUTO CLINICAL SAFETY LANCET - NORMAL

    MDR report key: 5018706 · Received August 12, 2015

    Report

    Report Number
    1058955-2015-00014
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    June 17, 2013
    Report Date
    August 5, 2015
    Manufacturer
    STAT MEDICAL DEVICES, INC.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL (B)(4), FOR THIS PRODUCT RETURN WAS CLOSED ON 10/31/2014. THIS NEW (B)(4) WAS OPENED AFTER CONSULTATION WITH THE EMERGO GROUP ON THE RE-ASSESSMENT OF THE MDR SUBMISSION FOR THIS RETURNED PRODUCT.

    Description of Event or Problem · 1

    IT TOOK FIVE (5) DEVICES TO PRODUCE A USABLE BLOOD SAMPLE IN THE PATIENT. THE TEN (10) RETURNED SAMPLES (ALL HAD BEEN FIRED) WERE VISUALLY INSPECTED AT 30X MAGNIFICATION FOR NEEDLE SHARPNESS AND CONTAMINATION. NO DEFECTS OR CONTAMINATION WAS OBSERVED. TEN (10) SAMPLES FROM THE SAME LOT (00275) WERE TESTED FOR PENETRATION USING THE FACTORY TEST. ALL PASSED. THE SPRING CONSTANT MEASUREMENTS FOR THE TWO SAMPLE SETS WERE MEASURED AND FOUND TO BE ALMOST IDENTICAL. SINCE THE SPRINGS IN THIS LOT OF PRODUCT ALL MEASURED IN THE ACCEPTABLE RANGE, PENETRATION TESTS ON PARTS FROM THE SAME LOT EXHIBITED ACCEPTABLE PENETRATION, AND NO DEFECTS WERE OBSERVED IN THE MICROSCOPIC INSPECTION OF THE RETURNED SAMPLES, THE COMPLAINT OF POOR PENETRATION DUE TO DEFECTIVE PRODUCT COULD NOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528949 STAT AUTO CLINICAL SAFETY LANCET - NORMAL AUTO - NORMAL FMK STAT MEDICAL DEVICES, INC. SAN-100 00275

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR