BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNISTIK 3 COMFORT

    MDR report key: 7920684 · Received September 28, 2018

    Report

    Report Number
    8021764-2018-00006
    Event Type
    Injury
    Date Received
    September 28, 2018
    Date of Event
    August 18, 2018
    Report Date
    February 19, 2019
    Manufacturer
    OWEN MUMFORD LIMITED
    Product Code
    FMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION WAS OPENED ON 25 SEP 2018 TO COVER SEVERAL COMPLAINTS OVER A 2 MONTH PERIOD STATING THAT UNISTIK 3 COMFORT DEVICE NEEDLES WERE NOT RETRACTING AFTER USE. FULL REPORT ATTACHED (INV-18-00064 REV 01).

    Description of Event or Problem · 1

    REGISTERED NURSE WAS PERFORMING A FINGER STICK ON PATIENT IN EMERGENCY DEPARTMENT AND WAS IN THE PROCESS OF PLACING THE LANCET DOWN ON A TABLE, WHEN SHE FELT A PRICK ON HER LEFT FOURTH FINGER. SHE NOTICED BLOOD IN HER GLOVE AND ALSO NOTICED THAT NEEDLE FROM LANCET WAS DANGLING AND DID NOT RETRACT PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758908 UNISTIK 3 COMFORT LANCET FMK OWEN MUMFORD LIMITED AT 1044 028164

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other