BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED FLO 100ML/HR

    MDR report key: 48630 · Received November 4, 1996

    Report

    Report Number
    48630
    Event Type
    Malfunction
    Date Received
    November 4, 1996
    Date of Event
    August 28, 1986
    Report Date
    November 2, 1996
    Manufacturer
    SECURE MEDICAL PROD
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    TUBING LEAKED AROUND FILTER (IN-LINE) AND ALLOWED MEDICATION TO LEAK OUT OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED FLO 100ML/HR ELASTOMERIC PUMP MEB SECURE MEDICAL PROD NA 6305

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other