BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN

    MDR report key: 1873130 · Received October 18, 2010

    Report

    Report Number
    1423500-2010-04569
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. THE SAMPLE HAS BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORT OF THE TWIST CLAMP BEING TOO TIGHT TO LOCK IN POSITION WAS CONFIRMED DURING EVALUATION. THE SET WAS VISUALLY INSPECTED WITH DAMAGE TO THE LIGHT BLUE BODY OBSERVED AT BOTH LOCKING PINS. NO OTHER MANUFACTURING ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION. PRESSURE TEST OF THE SAMPLE FOUND NO LEAKS. OPENING AND CLOSING OF THE CLAMP CONFIRMED DIFFICULTY IN THE PROCESS. ROOT CAUSE WAS UNDETERMINED. A BATCH REVIEW OF THE PRODUCTION LOT WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNKNOWN. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TWIST CLAMP WAS TOO TIGHT TO LOCK IN POSITION. THE SET HAD BEEN USED FOR 30 DAYS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE ACTUAL SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1