BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIVO 20G

    MDR report key: 17169944 · Received June 21, 2023

    Report

    Report Number
    17169944
    Event Type
    Malfunction
    Date Received
    June 21, 2023
    Date of Event
    June 3, 2023
    Report Date
    June 8, 2023
    Manufacturer
    VELANO VASCULAR, INC.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    USED A PIVO¿ NEEDLE-FREE BLOOD COLLECTION DEVICE TO DRAW BLOOD, GOT THE SAMPLE, WENT TO USE THE CLAMP TO TAKE THE DEVICE OUT, AND THE CLAMP BROKE. BLOOD CONTINUED TO COME OUT OF THE PIVO DEVICE EVEN AFTER SAMPLE WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171929 PIVO 20G TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA VELANO VASCULAR, INC. 202-0005 080917-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown