BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3023757 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07463
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER CANADA THAT A RECONSTITUTION DEVICE WAS LEAKING. THIS PRODUCT WAS BEING USED TO MIX ANGIOMAC WITH 50ML OF SALINE. THE REPORTED CONDITION OCCURRED DURING RECONSTITUTION. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125966 IVT DISPOSABLE SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - MALTA

    Patients

    Seq Age Sex Outcome Treatment
    1