BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.9 FR NEOMAGIC EPIV

    MDR report key: 9977104 · Received April 17, 2020

    Report

    Report Number
    MW5094189
    Event Type
    Malfunction
    Date Received
    April 17, 2020
    Date of Event
    March 20, 2020
    Report Date
    April 16, 2020
    Manufacturer
    NEO MEDICAL INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE 1.9 FR NEOMAGIC EPIV. DURING A DRESSING CHANGE WITH A PERIPHERAL IV, THE IV CATHETER SNAPPED IN HALF. THE REMAINING CATHETER THAT WAS STILL INSERTED IN THE PATIENT'S IV WAS ABLE TO BE REMOVED WITHOUT FURTHER TREATMENT. FDA SAFETY REPORT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435604 1.9 FR NEOMAGIC EPIV CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ NEO MEDICAL INC. 1033

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR