BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVACUATED CONTAINER

    MDR report key: 17240027 · Received June 29, 2023

    Report

    Report Number
    MW5119027
    Event Type
    Other
    Date Received
    June 29, 2023
    Report Date
    June 29, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    GCY
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AN ERROR THAT OCCURRED WAS DURING THE ORDERING PROCESS OF EVACUATED CONTAINERS FROM CARDINAL. EVACUATED GLASS CONTAINERS ARE NOT USED FOR MEDICATION; HOWEVER, THEY LOOK LIKE OTHER GLASS CONTAINERS THAT ARE USED FOR MEDICATION ADMIXING AND IV ADMINISTRATION. WHEN ORDERING THE EVACUATED CONTAINERS FROM CARDINAL THERE ISN'T A CLEAR AREA DURING THE ORDERING PROCESS WHERE THE PURCHASER CAN TELL THAT THE PRODUCT, THEY ARE ORDERING IS NOT FOR MEDICATION USE. OUR REGULAR MANUFACTURE HAD A SHORTAGE OF THE EVACUATED CONTAINERS WE NORMALLY ORDER SO WHEN OUR ORGANIZATION PURCHASED THESE CONTAINERS FROM CARDINAL THEY WERE NOT WHAT WE WERE USED TO SEEING AND USING. THEN THE CONTAINERS WERE ACCIDENTLY USED FOR/WITH MEDICATION, AND IT WASN'T UNTIL A NURSE NOTICED THAT THE BOTTLE SAID, "CAUTION NOT FOR MEDICATION ADMIXING, IV ADMINISTRATION, BLOCK COLLECTION, OR DIAGNOSTIC." AND ASKED IF IT WAS OKAY TO USE, DID WE NOTICE THE ERROR. POOR LABEL DESIGN (PHYSICAL LABEL): LABEL MISLEADING OR DIFFICULT TO READ. DRUG SHORTAGE, INADEQUATE SAFEGUARDS. .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255248 EVACUATED CONTAINER APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED GCY BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown