BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2000ML EVA TPN CONTAINER

    MDR report key: 1940040 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06288
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    April 15, 2010
    Report Date
    April 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF NO FLOW WAS CONFIRMED. A LEAK WAS NOTICED FROM THE INFUSION PORT. CLOSE VISUAL INSPECTION TO THE LEAKAGE AREA REVEALED A HOLE IN THE INFUSION PORT. BATCH FILE REVIEW DID NOT REVEAL ANY ISSUES RELATED TO THE REPORTED CONDITION. THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. (B)(4)

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(4) OF A NO FLOW WHEN CONNECTED TO THE PATIENT. ANOTHER BAG WAS PREPARED INSTEAD AND THE PATIENT RECEIVED HIS THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2000ML EVA TPN CONTAINER CONTAINER, I.V. KPE BAXTER HEALTHCARE - MALTA 09L04V852

    Patients

    Seq Age Sex Outcome Treatment
    1