BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLO-R 23G PUSH BUTTON

    MDR report key: 21253199 · Received January 28, 2025

    Report

    Report Number
    3001451226-2025-00002
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    December 9, 2024
    Report Date
    January 10, 2025
    Manufacturer
    INNOVATIVE MEDICAL TECHNOLOGIES, INC
    Product Code
    JKA
    PMA / PMN Number
    K220458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OPPORTUNITY FOR DEVICE IMPROVEMENT WAS IDENTIFIED. IMPROVEMENT HAS BEEN TESTED AND IMPLEMENTED IN ALL FUTURE PRODUCTION LOTS. 160 SAMPLES FROM SEVERAL LOTS WERE TESTED AND THE ISSUE COULD NOT BE REPRODUCED.

    Description of Event or Problem · 0

    NEEDLE DOES NOT RETRACT COMPLETELY UPON ACTIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2405515 ULTRAFLO-R 23G PUSH BUTTON TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLO JKA INNOVATIVE MEDICAL TECHNOLOGIES, INC 364 240127M

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention