BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3203618 · Received July 3, 2013

    Report

    Report Number
    1416980-2013-17109
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Report Date
    June 10, 2013
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. THE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT WHITE PARTICLES WERE VISIBLE ON THE BAGS, HENCE OUTSIDE THE FLUID PATHWAY. THE CAUSE WAS DETERMINED TO BE A MANUFACTURING ISSUE. UPDATES WERE MADE TO THE MANUFACTURING PROCESS AS A CORRECTIVE ACTION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 250 ML EVA BAG WAS OBSERVED TO HAVE A PARTICLE INSIDE THE PRIMARY BAG. THIS MALFUNCTION WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304274 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - MALTA 11J27V259

    Patients

    Seq Age Sex Outcome Treatment
    1