BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNICELL I.V.STATION ONCO

    MDR report key: 9616930 · Received January 22, 2020

    Report

    Report Number
    3011278888-2020-00002
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Date of Event
    January 13, 2020
    Report Date
    May 18, 2021
    Manufacturer
    OMNICELL, INC.
    Product Code
    NEP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF (B)(6) 2020, THE ESTABLISHMENT REGISTRATION AND LISTING FOR THIS DEVICE WAS UPDATED TO OMNICELL, INC. FROM AESYNT, INC, WHICH WAS NOT REFLECTED IN THE ORIGINAL REPORT SUBMISSION. THEREFORE, THIS REPORT IS A CORRECTION TO THE MANUFACTURER LISTED IN SECTION D3.

    Description of Event or Problem · 1

    ON (B)(6) 2020 AN I.V. STATION MISLABELED A SYRINGE PREPARATION. A FAILURE TO APPROPRIATELY FEED THE LABEL RESULTED IN AN UNLABELED SYRINGE (THE INTENDED DRUG PREPARATION) AND A MISLABELED SYRINGE WHEN THE INCOMPLETELY FED LABEL WAS UNINTENTIONALLY APPLIED TO THE FOLLOWING SYRINGE. BOTH THE UNLABELED AND MISLABELED PREPARATIONS WERE IDENTIFIED AND DISCARDED. AN ADJUSTMENT WAS MADE TO THE PRINTER LABEL EXIT PARAMETER TO PREVENT RECURRENCE. THERE IS NO ADVERSE PATIENT EFFECT RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81748 OMNICELL I.V.STATION ONCO PHARMACY COMPOUNDING DEVICE NEP OMNICELL, INC. I.V. STATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other