BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KURIN BLOOD CULTURE COLLECTION SET

    MDR report key: 21228563 · Received January 24, 2025

    Report

    Report Number
    21228563
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    January 20, 2025
    Report Date
    January 21, 2025
    Manufacturer
    KURIN, INC.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    KURIN BUTTERFLY NEEDLE SYSTEM USED X3 IN ATTEMPT TO OBTAIN BLOOD CULTURES FROM PATIENT (PT.), EACH TIME THE NEEDLE AUTO-RETRACTED WITHOUT BUTTON BEING TOUCHED WHEN PARAMEDIC WAS ATTEMPTING BLOOD DRAW. LOT NUMBER FOR ALL 3 IS 8618-051324-F1 AND SAME EXPIRATION DATE OF 2026-05-13. RESULTED IN UNNECESSARY POKES FOR LABS FOR PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708175 KURIN BLOOD CULTURE COLLECTION SET TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA KURIN, INC. TJ-221 8618-051324-F1

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male