BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 4233749 · Received November 6, 2014

    Report

    Report Number
    1416980-2014-39199
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 1, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL AND MICROSCOPIC INSPECTION REVEALED A DAMAGED PATIENT ADAPTER. LEAK TESTING, CLEAR PASSAGE TESTING, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE CAUSE WAS UNABLE TO BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A UV-FLASH SOLUTION TRANSFER SET SHORT, A DAMAGED PATIENT CONNECTOR WAS FOUND. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715682 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1