BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON BRANDS

    MDR report key: 23767443 · Received December 10, 2025

    Report

    Report Number
    1451040-2025-00120
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 10, 2025
    Manufacturer
    HARSORIA HEALTHCARE
    Product Code
    QOI
    UDI-DI
    10612479268026
    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 THE 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 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
    2867153 MCKESSON BRANDS CATH, IV SFTY STR PUSH BUTTON BC BLU 22GX1" QOI HARSORIA HEALTHCARE 41209/0759 10612479268026

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown