BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH SOLUTION TRANSFER SET(SHORT) - JAPAN

    MDR report key: 1900755 · Received November 16, 2010

    Report

    Report Number
    1423500-2010-05834
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 21, 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). THE ACTUAL SAMPLE WAS RECEIVED AND EVALUATED. THIS COMPLAINT WAS CONFIRMED IN THE LAB TO HAVE A BENT SPIKE TIP. THE ROOT CAUSE IS UNDETERMINED. IN THIS CASE THE DEFECT WAS OBSERVED DIRECTLY AFTER CLEAN FLASH USAGE. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS REQUESTED. IF THE DEVICE IS RETURNED FOR EVALUATION THEN A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE SPIKE OF THE UV FLASH TRANSFER SET BENT DUE TO MISSPIKE BY CLEAN FLASH. (B)(4). 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