BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODAN

    MDR report key: 18483217 · Received January 10, 2024

    Report

    Report Number
    18483217
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    December 23, 2023
    Report Date
    December 27, 2023
    Manufacturer
    CODAN US CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WE HAVE HAD TWO INSTANCES OF THE DEVICE CRACKING WHERE IT CONNECTS TO THE PATIENT IV CAUSING LEAKING. IN THIS CASE THE PATIENT WAS NOTED TO HAVE A DECREASED MAP. THE DEVICE WAS ASSESSED, AND IT WAS NOTED THE MANIFOLD WITH PRESSORS CRACKED AND LEAKING IV MEDICATIONS INTO THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142052 CODAN SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORPORATION BC 252

    Patients

    Seq Age Sex Outcome Treatment
    1 25550 DA Female