BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCETS

    MDR report key: 2532389 · Received April 6, 2012

    Report

    Report Number
    MW5024976
    Event Type
    Malfunction
    Date Received
    April 6, 2012
    Date of Event
    April 4, 2012
    Report Date
    April 6, 2012
    Manufacturer
    BD
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    LANCETS WITH LOT # 2110820, PRODUCT # 202T, NDC # (B)(4): ENTIRE NEEDLE SLIPS OUT OF THE PLASTIC BASE WHEN REMOVING THE TIP. LANCETS ARE BLUE, AND HAVE 2 NOTCHES ON ONE SIDE AND ONE NOTCH ON THE OTHER. NEEDLE BASE IS VISIBLE THROUGH THE HOLES ON THE SIDE WITH 2 NOTCHES ONLY. THE OTHER SIDE IS SOLID. PT REPORTS NOT ALL LANCETS IN THE BOX ARE DEFECTIVE. DATES OF USE: (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANCETS LANCETS FMK BD 2110820

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR