BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3083572 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10739
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION, FILLED WITH TOTAL PARENTERAL NUTRITION. VISUAL INSPECTION REVEALED THAT THE BAG HAD A PARTICLE INSIDE, WHICH CONFIRMED THE REPORTED CONDITION. HOWEVER, THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE FINE "THREAD-LIKE FIBERS" IDENTIFIED IN A 250ML EVA BAG. THERE WAS NO REPORT OF PATIENT INVOLVEMENT NOR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184897 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - MALTA 12A24V214

    Patients

    Seq Age Sex Outcome Treatment
    1