BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT COMFORT THIN LANCET - PULL OFF

    MDR report key: 5021552 · Received August 13, 2015

    Report

    Report Number
    1058955-2015-00018
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    March 28, 2014
    Report Date
    August 10, 2015
    Manufacturer
    STAT MEDICAL DEVICES, INC.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED THAT IN ONE ARRIVAL OF LANCET 33G, BATCH 00314A CUSTOMER FOUND TWO OUTER OF LANCET 28G BATCH 00315A (CATALOG SM-SCR-100) BUT INSIDE THERE WERE BOXES OF BATCH 00314A. MOREOVER ONE BOX OF BATCH 00315A WAS FOUND. IMPROPER HANDLING CAUSED LOT CO-MINGLING AT MANUFACTURING FACILITY. LOT CO-MINGLING RESULTED FROM IMPROPER WORKPLACE CLEARANCE DURING THE PACKAGING OPERATIONS OF LOT 00314A, PRIOR TO INITIATION OF PACKAGING 00315A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535563 STAT COMFORT THIN LANCET - PULL OFF TWIST OFF LANCET FMK STAT MEDICAL DEVICES, INC. SCU-100 00314A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other