BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILIZED 201-0006 EXT EXTENSION SET

    MDR report key: 17143577 · Received June 15, 2023

    Report

    Report Number
    MW5118435
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    June 6, 2023
    Report Date
    June 13, 2023
    Manufacturer
    VELANO VASCULAR
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    RN (REGISTERED NURSE) WENT IN TO FLUSH PATIENTS IV (INTRAVENOUS) AND HANG ANTIBIOTIC AND FLUIDS AND WHEN RN FLUSHED THE IV IT SHOT BACK AT HER THROUGH THE PIVO PORT AND SHOT HER IN HER RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709507 STABILIZED 201-0006 EXT EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA VELANO VASCULAR 9453333

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female