BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3080999 · Received April 26, 2013

    Report

    Report Number
    1416980-2013-10521
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 1, 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). (B)(6). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A 500ML EVA BAG FOR AUTOMIX HAD FINE THREAD-LIKE FIBERS IN THE BAG. 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
    182798 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - MALTA 12I30V864

    Patients

    Seq Age Sex Outcome Treatment
    1