BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON BRANDS

    MDR report key: 23254446 · Received October 9, 2025

    Report

    Report Number
    1451040-2025-00092
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 9, 2025
    Manufacturer
    HARSORIA HEALTHCARE
    Product Code
    QOI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE DOESN'T FULLY RETRACT AND STAYS EXTERNAL. IF YOU TIP THE NEEDLE UPSIDE DOWN AFTER RETRACTING IT, IT FALLS OUT.. NO OTHER INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2481114 MCKESSON BRANDS CATH, IV SFTY STR PUSH BUTTON BC BLU 22GX1" QOI HARSORIA HEALTHCARE 40945/0573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown