BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAVIA CONTAINER EMPTY

    MDR report key: 6100759 · Received November 14, 2016

    Report

    Report Number
    1416980-2016-17291
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Report Date
    December 15, 2016
    Manufacturer
    BAXTER HEALTHCARE - DOMINICAN REPUBLIC
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICE WAS FOUND TO FLOW NORMALLY WITH NO ISSUES NOTED. THE REPORTED CONDITION 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 AN INTRAVIA CONTAINER HAD A FLOW ISSUE. THE BAG DOES NOT FIT PROPERLY IN THE LOCKED CASE AND DISRUPTS THE FLOW OF SOLUTION. THIS OCCURRED DURING USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751350 INTRAVIA CONTAINER EMPTY CONTAINER, I.V. KPE BAXTER HEALTHCARE - DOMINICAN REPUBLIC NA DR16F06055

    Patients

    Seq Age Sex Outcome Treatment
    1 EPIDURAL NARCOTIC