BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 3254063 · Received July 30, 2013

    Report

    Report Number
    1416980-2013-20132
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    June 10, 2013
    Report Date
    July 5, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION AND EVALUATION CONFIRMED THE REPORTED PROBLEM. THE CAUSE WAS DETERMINED TO BE RELATED TO THE MANUFACTURING PROCESS OF THE INTERNAL SUPPLIER. IN ORDER TO ADDRESS THIS CONDITION; THE INTERNAL SUPPLIER WAS NOTIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PARTICULATE MATTER WAS OBSERVED INSIDE AN INTRAVIA 150 ML CONTAINER CONTAINING DEFEROXAMINE. THIS ISSUE WAS DISCOVERED BEFORE USE, THEREFORE THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354292 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR13D15112

    Patients

    Seq Age Sex Outcome Treatment
    1