BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 4153034 · Received October 8, 2014

    Report

    Report Number
    1416980-2014-35041
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3000 ML EVA BAG LEAKED TOTAL PARENTERAL NUTRITION SOLUTION INTO ITS OVERPOUCH. THIS WAS NOTICED BY THE HOME PATIENT BEFORE USE IN THERAPY. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632152 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - MALTA 13K11V510

    Patients

    Seq Age Sex Outcome Treatment
    1