BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 4233902 · Received November 7, 2014

    Report

    Report Number
    1416980-2014-39223
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE SMALL, PLASTIC PARTICLES INSIDE OF AN INTRAVIA 150 ML CONTAINER. THE REPORTER STATED THAT ¿SOME¿ OF THE PARTICLES HAD A BLACK INK STAMP ON THEM. THIS WAS NOTICED DURING COMPOUNDING WITH SALINE AND FENTANYL AND BEFORE PATIENT USE. THE REPORTER STATED THAT THIS SOLUTION WAS FILTERED BEFORE USE WITH THE CONTAINER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 28 OF 60.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716701 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR14E20092

    Patients

    Seq Age Sex Outcome Treatment
    1