BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUSH BUTTON BLOOD COLLECTION KITS

    MDR report key: 22060569 · Received May 21, 2025

    Report

    Report Number
    MW5170639
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    May 12, 2025
    Report Date
    July 2, 2025
    Manufacturer
    INNOVATIVE MEDICAL TECHNOLOGIES, INC.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PUSH BUTTON DEVICE FAILED TO RETRACT NEEDLE COMPLETELY INTO COVER. POTENTIAL FOR DIRTY NEEDLE STICKS. SECOND DEVICE FELL APART AT BED SIDE. REF REPORT: MW5170640.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 07/02/2025 FOR MW5170639 TO UPDATE MANUFACTURER. PUSH BUTTON DEVICE FAILED TO RETRACT NEEDLE COMPLETELY INTO COVER. POTENTIAL FOR DIRTY NEEDLE STICKS. SECOND DEVICE FELL APART AT BED SIDE. REF REPORT: MW5170640.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2321038 PUSH BUTTON BLOOD COLLECTION KITS TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA INNOVATIVE MEDICAL TECHNOLOGIES, INC. 365 250104M

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown