BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON BRANDS

    MDR report key: 23719643 · Received December 4, 2025

    Report

    Report Number
    1451040-2025-00116
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 21, 2025
    Report Date
    December 4, 2025
    Manufacturer
    HARSORIA HEALTHCARE
    Product Code
    QOI
    UDI-DI
    10612479267968
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT CATHETER APPEARS TO BE OCCLUDED CAUSING FORCE TO BE USED TO PUSH THE PLUNGER. THIS RESULTS IN LEAKAGE DUE TO THE PRESSURE USED. THE CUSTOMER ALSO REPORTED THAT THE NEEDLE DOESN'T RETRACT AFTER PUSHING THE BUTTON. NO 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
    139816 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