BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC

    MDR report key: 11649272 · Received April 12, 2021

    Report

    Report Number
    3012307300-2021-03068
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    March 15, 2021
    Report Date
    September 7, 2021
    Product Code
    FPA
    UDI-DI
    10610586027741
    PMA / PMN Number
    K021999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS IN USE WITH PATIENT AND DEVICE SHOWED AIR IN THE TUBING. NO ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545038 DELTEC SET, ADMINISTRATION, INTRAVASCULAR, FPA 21-2966-24 4057906 10610586027741

    Patients

    Seq Age Sex Outcome Treatment
    1