BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAEMOLANCE LANCET

    MDR report key: 996264 · Received January 31, 2008

    Report

    Report Number
    1832816-2008-00006
    Event Type
    Injury
    Date Received
    January 31, 2008
    Date of Event
    December 26, 2007
    Report Date
    January 16, 2008
    Manufacturer
    ARTA PLAST A-B
    Product Code
    FMK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCIDENTAL NEEDLE STICK WITH A HAEMOLANCE LANCET AT A CORRECTIONAL FACILITY. HAPPENED IN 2007 - 25 GAUGE NEEDLE USED. LOW FLOW, DIRTY NEEDLE. IT HAD BEEN USED ON AN INMATE. WOULD NOT GIVE ANY MORE DETAILS. WILL NOT GIVE THE PERSON'S NAME DUE TO CONFIDENTIALITY. WENT TO ER, HAD BLOOD DRAWN AND FULL BLOOD WORK DONE, PEP KIT. HE DID NOT CONTRAST ANYTHING THAT THEY KNOW OF. DID HIV/VIRAL LOAD AND STARTED HIM ON PEP KIT WHICH IS HIV MED. DEPENDING ON THE RESULTS OF THE VIRAL LOAD THEY MAY STOP THE HIV MED AFTER 6 MONTHS. THE INCIDENT IS RARE AND IT WAS HUMAN ERROR. SUGGESTED THEY UPGRADE TO THE HAEMOLANCE PLUS. PRODUCT WAS DISCHARGED AND LOT NUMBER IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAEMOLANCE LANCET LANCET FMK ARTA PLAST A-B 990550 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention