BEUDAMED
    FDA Adverse Event Injury Summary report: N

    YUME SET FOR UV FLASH

    MDR report key: 1971138 · Received January 26, 2011

    Report

    Report Number
    1423500-2011-01045
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    April 25, 2010
    Report Date
    April 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE NO EVALUATION WAS PERFORMED. THE ROOT CAUSE FOR THIS INCIDENT IS UNDETERMINED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED BATCH WITH NO ABNORMALITY OBSERVED. THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THIS EVENT IS ASSOCIATED WITH MANUFACTURER REPORT NUMBER: 1423500-2010-02745.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM (B)(4) OF PERITONEAL CLOUDY EFFLUENT IN A MALE PATIENT COINCIDENT WITH DIANEAL N THERAPY. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL N 1.5% INTRAPERITONEALLY (IP). ON (B)(6) 2010, THE PATIENT HAD PERITONEAL CLOUDY EFFLUENT. NO TREATMENT WAS GIVEN TO THE PATIENT. ON (B)(6) 2010, THE PATIENT WAS RECOVERED FROM THE EVENT. HIS PD THERAPY WAS ONGOING. PER THE PHYSICIAN, THE EVENT WAS NON-SERIOUS AND THE EVENT WAS POSSIBLY RELATED TO BOTH DIANEAL N AND MEDICAL DEVICES (UV TRANSFER SET, PD CATHETER, AND APD SET).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 YUME SET FOR UV FLASH SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SINGAPORE S10B05045

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention