BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3141051 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14010
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED LEAKAGE FROM A CRACK IN THE TUBE. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS DUE TO LEAKAGE FROM A CRACK IN THE TUBE AND WAS HOSPITALIZED. ON AN UNREPORTED DATE, THE PATIENT RECEIVED UNSPECIFIED ANTIBIOTIC TREATMENT FOR PERITONITIS. THE OUTCOME OF THE CRACKED TUBING WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245176 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL-N PD-4 1.5