BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SET

    MDR report key: 3243062 · Received July 23, 2013

    Report

    Report Number
    1416980-2013-19465
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    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). DIMENSIONAL INSPECTION OF THE RETURNED TRANSFER SET SAMPLE IDENTIFIED THAT THE INSIDE DIAMETER OF THE PATIENT CONNECTOR OF THE RETURNED TRANSFER SET SAMPLE WAS IDENTIFIED TO BE OUT OF SPECIFICATION. IMPROVEMENTS WERE MADE TO THE MOLD AND MOLDING DEPARTMENT PROCEDURES. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING SAMPLE EVALUATION OF A TRANSFER SET FOR A LEAK, IT WAS NOTED THAT THE ID PATIENT CONNECTOR MEASURED OUTSIDE SPECIFICATION RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343732 UV FLASH TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1