BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN

    MDR report key: 1984388 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01768
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    September 14, 2010
    Report Date
    September 17, 2010
    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). 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 OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S. ONE USED SAMPLE WAS RECEIVED IN REFERENCE TO THE REPORT OF DAMAGED SPIKE. THE SET WAS VISUALLY INSPECTED WITH BENT/DAMAGED SPIKE OBSERVED. THE TIP OF THE SPIKE WAS BENT/DAMAGED. NO OTHER MANUFACTURING ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION. PRESSURE TEST OF SAMPLE FOUND NO LEAKS. THIS COMPLAINT WAS CONFIRMED IN THE LAB. NO BATCH REVIEW COULD BE PERFORMED SINCE THE LOT NUMBER WAS UNKNOWN. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT THE SPIKE WAS BENT WHEN THE TRANSFER SET WAS CONNECTED TO THE YUME SET BY A CLEAN FLASH DEVICE DURING PATIENT USE. THE TRANSFER SET HAD BEEN USED ON THE PATIENT FOR 98 DAYS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    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