BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAGFLOW

    MDR report key: 8523297 · Received April 17, 2019

    Report

    Report Number
    8523297
    Event Type
    Malfunction
    Date Received
    April 17, 2019
    Date of Event
    April 1, 2019
    Report Date
    April 2, 2019
    Manufacturer
    MEDICAL SPECIALTY INNOVATIONS, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    UPON GETTING DEVICE FROM EXCHANGE CART NOTICED IN PACKAGING FOREIGN SUBSTANCE LIKE A BUG IN PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316167 BAGFLOW PUMP, INFUSION FRN MEDICAL SPECIALTY INNOVATIONS, INC. 2988

    Patients

    Seq Age Sex Outcome Treatment
    1