BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMART DOSE

    MDR report key: 22580 · Received June 20, 1995

    Report

    Report Number
    MW1006289
    Event Type
    Malfunction
    Date Received
    June 20, 1995
    Date of Event
    June 6, 1995
    Report Date
    June 15, 1995
    Manufacturer
    RIVER MEDICAL, INC.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    NURSE WAS PREPARING TO ADMINISTER MEDICATION WHICH WAS COMPOUNDED BY THE PHARMACY. TO ADMINISTER, THE PUMP NEEDED TO BE "ACTIVATED". WHEN NURSE PUSHED IN ON THE PLASTIC AREA TO ACTIVATE PUMP, THE CITRIC ACID 'BATH' WAS EJECTED OUT OF PLASTIC CONTAINERS INTO HIS EYES. AN EYE WASH WAS DONE IMMEDIATELY FOLLOWING INCIDENT. THE FOLLOWING DAY, NURSE WENT TO URGENT CARE CLINIC AND NO FURTHER INTERVENTION WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMART DOSE PUMP MEB RIVER MEDICAL, INC. 001002 4100164

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR