BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3191430 · Received June 26, 2013

    Report

    Report Number
    1416980-2013-16494
    Event Type
    Malfunction
    Date Received
    June 26, 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). IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT WHITE PARTICLES WERE VISIBLE ON THE BAG, 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.

    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
    291454 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - MALTA 11J27V259

    Patients

    Seq Age Sex Outcome Treatment
    1