BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3090665 · Received May 2, 2013

    Report

    Report Number
    1416980-2013-11162
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 8, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). EVALUATION SUMMARY: A BATCH REVIEW WAS PERFORMED AND DID NOT REVEAL ANY ISSUES RELATED TO THE REPORTED CONDITION. THE SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED A WHITE PARTICLE INSIDE THE BAG. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY THE BAXTER MANUFACTURING PLANT, IT WAS IDENTIFIED THAT THE EVA BAG FOR AUTOMIX HAD AN UNKNOWN WHITE PARTICLE INSIDE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192044 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - MALTA 11J31V162

    Patients

    Seq Age Sex Outcome Treatment
    1