BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 4031499 · Received August 22, 2014

    Report

    Report Number
    1416980-2014-27730
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Report Date
    July 30, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVALUATION IS COMPLETE. THE DAMAGED PATIENT CONNECTOR WAS IDENTIFIED DURING VISUAL INSPECTION. LEAK (UNDER WATER, USING PRESSURE), CLEAR PASSAGE, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED; THE DEVICE PASSED THESE TESTS. THE CAUSE WAS UNABLE TO BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS THE SAME DEVICE AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED UV FLASH TRANSFER SET, THE PATIENT CONNECTOR WAS NOTED TO BE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509156 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1