BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIVO

    MDR report key: 9348777 · Received November 19, 2019

    Report

    Report Number
    MW5091184
    Event Type
    Malfunction
    Date Received
    November 19, 2019
    Date of Event
    August 21, 2019
    Report Date
    October 20, 2019
    Manufacturer
    VELANO VASCULAR
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PHLEBOTOMIST

    Narratives

    Description of Event or Problem · 1

    I WAS DRAINING A PT'S BLOOD USING A PIVO DEVICE AND GOT SPLASHED IN THE FACE WITH THE PT'S BLOOD WHEN I THREW DEVICE AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137238 PIVO TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA VELANO VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other