BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAXTER HEALTHCARE CORP.

    MDR report key: 3966523 · Received July 25, 2014

    Report

    Report Number
    MW5037488
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 24, 2014
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    INFUSION PATIENT USING VIAL-MATE ADAPTER PRODUCT TO MIX MEDICATION AND SALINE FOR IV USE. AFTER INSERTING VIAL-MATE INTO MEDICATION VIAL, PATIENT NOTICED DARK PARTICLES FLOATING IN THE MEDICATION WITHIN THE VIAL, NOT WANTING TO INFUSE THIS, PATIENT CALLED PHARMACY TO INFORM PHARMACIST. THE VIAL, VIAL-MATE AND SALINE BAG WERE RETURNED TO PHARMACY, UNUSED BY THE PATIENT. THE VIAL-MATE ADAPTOR CORED THE VIAL SEAL AND PARTICLES OF THE SEAL WERE INCORPORATED TO THE MEDICATION. THE OUTCOME OF THIS EVENT COULD HAVE BEEN LIFE THREATENING IF THE PATIENT HAD INFUSED THE MEDICATION WITH PARTICLES. THE VIAL-MATE ADAPTOR WILL BE RETURNED TO THE MANUFACTURER AND THE MANUFACTURER IS INFORMED OF THE MEDWATCH REPORT. DATES OF USE: (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: IV THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436552 BAXTER HEALTHCARE CORP. VIAL-MATE ADAPTOR LHI BAXTER INTERNATIONAL INC. 2B8071

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening