BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 17508861 · Received August 11, 2023

    Report

    Report Number
    1416980-2023-04035
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    July 18, 2023
    Report Date
    August 15, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: THE DATE OF EVENT WAS INADVERTENTLY SUBMITTED AS 07/19/2023; HOWEVER, THE CORRECT DATE OF EVENT IS 07/19/2023. DATE RECEIVED BY MFR: THE INITIAL MDR G3 DATE WAS INADVERTENTLY SUBMITTED AS 7/18/2023; HOWEVER, THE CORRECT DATE IS 07/19/2023. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS. THE CAUSE AND TREATMENT WERE NOT REPORTED. THE PATIENT WAS HOSPITALIZED DUE TO THE EVENT. AT THE TIME OF THIS REPORT, THE PATIENT HAS RECOVERED FROM THE EVENT. PD THERAPY WAS ONGOING. THE REPORTER DECLINED TO PROVIDE ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941076 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization KAGUYA| REGUNEAL LCA 1.5