BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNISTIK 3 COMFORT

    MDR report key: 7920709 · Received September 28, 2018

    Report

    Report Number
    8021764-2018-00005
    Event Type
    Injury
    Date Received
    September 28, 2018
    Date of Event
    July 14, 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 UNISITK 3 COMFORT DEVICE NEEDLES WERE NOT RETRACTING AFTER USE. FULL REPORT ATTACHED (INV-18-00064 REV 01). - ATTACHMENT: [INV-18-00064 REV. 01.PDF].

    Description of Event or Problem · 1

    PREGNANT NURSING ASSISTANT JUST FINISHED PERFORMING A BLOOD SUGAR CHECK ON A PATIENT AND WENT TO DISPOSE OF LANCET INTO SHARPS CONTAINER AND FELT A PRICK. NURSING ASSISTANT THEN LOOKED AT LANCET BEFORE DISPOSING AND NOTICED THAT THE NEEDLE DID NOT RETRACT COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759308 UNISTIK 3 COMFORT LANCET FMK OWEN MUMFORD LIMITED AT 1044 028164

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other