BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NNI

    MDR report key: 5295505 · Received December 14, 2015

    Report

    Report Number
    1416980-2015-44345
    Event Type
    Injury
    Date Received
    December 14, 2015
    Date of Event
    November 13, 2015
    Report Date
    December 14, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEDIATRIC PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE PERITONITIS WAS REPORTED AS THE PATIENT SCRATCHED NEAR CATHETER SITE AND THEY THINK IT TRAVELED DOWN; HOWEVER, THIS COULD NOT BE CLARIFIED, THEREFORE, THE CAUSE OF THE EVENT WAS ASSESSED AS UNKNOWN. THE DAY AFTER THE EVENT ONSET, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. TREATMENT DETAILS WERE NOT REPORTED. DIANEAL THERAPY REMAINED ONGOING. TWO DAYS AFTER ADMISSION, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT IS RECOVERING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824873 NNI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Hospitalization DIANEAL 1.5% PD4 AMBUFLEX