BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVIA CONTAINER EMPTY

    MDR report key: 6071046 · Received November 1, 2016

    Report

    Report Number
    1416980-2016-16858
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Report Date
    October 12, 2017
    Manufacturer
    BAXTER HEALTHCARE - DOMINICAN REPUBLIC
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: (B)(6) 2016. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    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 RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    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 FOUND INSIDE A INTRAVIA CONTAINER. THE REPORTER STATED THAT A SMALL CLEAR PIECE OF PLASTIC WAS DISCOVERED AFTER SPIKING THE BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719750 INTRAVIA CONTAINER EMPTY CONTAINER, I.V. KPE BAXTER HEALTHCARE - DOMINICAN REPUBLIC NA DR15L14059

    Patients

    Seq Age Sex Outcome Treatment
    1