BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2851479 · Received November 29, 2012

    Report

    Report Number
    1416980-2012-06154
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE SAMPLE WAS RETURNED FOR EVALUATION. DURING VISUAL INSPECTION AND FUNCTIONAL TESTING THE CUSTOMER REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE AN INTRAVIA EMPTRY CONTAINER IN WHICH A LEAK OCCURRED. ACCORDING TO THE REPORT, THE STAFF MEMBER AT THE FACILITY OBSERVED A LEAK OUT OF THE BONDED JUNCTION BETWEEN THE PORT TUBING AND THE BAG. THE EVENT OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT, INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR12H11030

    Patients

    Seq Age Sex Outcome Treatment
    1