BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAEMOLANCE PLUS LANCETS

    MDR report key: 451973 · Received April 3, 2003

    Report

    Report Number
    1832816-2003-00004
    Event Type
    Injury
    Date Received
    April 3, 2003
    Date of Event
    February 27, 2003
    Report Date
    March 6, 2003
    Manufacturer
    ARTA PLAST AB
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN LPN STUCK A HIGH-RISK PT FOR A BLOOD GLUCOSE TEST. THE NURSE SET THE NEEDLE ON THE BEDSIDE STAQND AND IT ROLLED OFF ONTO THE GROUND. THE NURSE WENT OT PICK UP THE LANCET AND STUCK THEMSELF. THE NURSE CLAIMED THAT THE NEEDLE WAS OUTSIDE OF THE PLASTIC CASE EVEN THOUGH IT WAS SUPPOSE TO RETRACT. THE NURSE MADE THEMSELVES BLEED, THEN CLEANED THE WOUND WITH BHIBICLEANSE AND BANDAGE THE AREA. THE NURSE DID NOT RECEIVE A TETANUS SHOT AS THEY HAVE HAD ONE IN THE PAST 10 YEARS, WHICH THEY BECAME SICK FROM. THEY DID NOT RECEIVE A GAMMA GLOBULIN SHOT OR STITCHES. THE BOX THAT THE LANCETS CAME FROM WAS THROWN AWAY SO THE LOT NUMBER IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAEMOLANCE PLUS LANCETS LANCETS FMK ARTA PLAST AB 990900 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention