BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 10241070 · Received July 7, 2020

    Report

    Report Number
    3012307300-2020-06703
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 1, 2020
    Report Date
    August 21, 2020
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586027307
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 0

    ORACLE RO 1072182: HIGH FLOW. UPDATE ORACLE RO 1075297: HIGH FLOW. EVALUATION COMPLETED IN H 10.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL CADD ADMINISTRATION SET DID NOT INFUSE EPIDURAL MEDICATION. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704176 CADD SET, ADMINISTRATION, INTRAVASCULAR FRN ST PAUL 2120 3976365 10610586027307

    Patients

    Seq Age Sex Outcome Treatment
    1