BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWONIX CATHETER

    MDR report key: 23758134 · Received December 9, 2025

    Report

    Report Number
    MW5180179
    Event Type
    Injury
    Date Received
    December 9, 2025
    Report Date
    December 5, 2025
    Manufacturer
    FLOWONIX / INFUSYN THERAPEUTICS
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD A FLOWONIX CATHETER THAT WAS NOT ABLE TO BE ASPIRATED AT A PREVIOUS DYE STUDY, OR DURING THE REPLACEMENT OF HER PUMP. PATIENT HAD BEEN EXPERIENCING AN INCREASE OF PAIN AND SOME NAUSEA AND DIZZINESS THE LAST SEVERAL MONTHS. NO VOLUME DISCREPANCIES WERE FOUND AT REFILLS AND NO DOSE CHANGES HAD OCCURRED. AFTER CATHETER REPLACEMENT, HCP WAS ONCE AGAIN UNABLE TO ASPIRATE THE CATHETER. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)". PT CODES: 1994, 1970, 2194. DEVICE CODE: 2170. REF REPORT: MW5180178.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2718715 FLOWONIX CATHETER PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK FLOWONIX / INFUSYN THERAPEUTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown