BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 4233151 · Received November 6, 2014

    Report

    Report Number
    1416980-2014-39177
    Event Type
    Malfunction
    Date Received
    November 6, 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). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, AN UNUSED DEVICE OF THE SAME LOT WAS RECEIVED. THE UNUSED DEVICE WAS RECEIVED WITHOUT ITS ORIGINAL PACKAGING. VISUAL INSPECTION (VIA THE NAKED EYE) OF THE EMPTY BAG REVEALED NO EVIDENCE OF PARTICULATE MATTER. THE DEVICE WAS THEN FILLED WITH STERILE WATER AND AGAIN INSPECTED FOR PARTICULATE MATTER; NO PARTICULATE MATTER IN THE FLUID PATH WAS OBSERVED. THE REPORTED PROBLEM WAS NOT VERIFIED. 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 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. 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 25 OF 40.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715653 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR14D02010

    Patients

    Seq Age Sex Outcome Treatment
    1