BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIVO 22G

    MDR report key: 15470069 · Received September 23, 2022

    Report

    Report Number
    15470069
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Date of Event
    August 22, 2022
    Report Date
    September 7, 2022
    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

    REGISTERED NURSE (RN) WAS USING A PIVO¿ BLOOD COLLECTION DEVICE TO DRAW BLOOD. WHEN RN WAS REMOVING PIVO, RN NOTICED CATHETER BROKE. RN WAS CAREFUL TO UNATTACHED PIVO AND GRAB THE CATHETER THAT WAS IN THE PATIENT'S ARM AND PULL IT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567273 PIVO 22G TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA VELANO VASCULAR, INC. 202-0006 081921-04

    Patients

    Seq Age Sex Outcome Treatment
    1 25550 DA Male