BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON BRANDS

    MDR report key: 23631787 · Received November 24, 2025

    Report

    Report Number
    1451040-2025-00114
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    October 31, 2025
    Report Date
    November 24, 2025
    Manufacturer
    HARSORIA HEALTHCARE
    Product Code
    QOI
    UDI-DI
    10612479267968
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN THE NEEDLE IS NOT RETRACTING BACK AFTER PUSHING THE BUTTON, CAUSING LEAKING AT THE CATHETER SITE WHILE PERFORMING AN IV ON A PATIENT. 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
    2390547 MCKESSON BRANDS CATH, IV SFTY STR PUSH BUTTON BC PNK 20GX1" QOI HARSORIA HEALTHCARE 40576/0360 10612479267968

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown