BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 10321242 · Received July 24, 2020

    Report

    Report Number
    1416980-2020-04282
    Event Type
    Injury
    Date Received
    July 24, 2020
    Report Date
    July 24, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS RECEIVED FROM A LITERATURE ARTICLE. SINHA S, FOK M, DAVENPORT A, ET AL. USE OF THE EMBEDDED PERITONEAL DIALYSIS CATHETER. ANN R COLL SURG ENGL. 2018;100(7):534-544. DOI:10.1308/RCSANN.2018.0088. 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 · 1

    IT WAS REPORTED THAT DURING A STUDY, 18 PERITONEAL DIALYSIS (PD) PATIENTS EXPERIENCED SEVERAL EPISODES OF PERITONITIS. THE CAUSE AND TREATMENT WERE NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENTS WERE HOSPITALIZED FOR THE EVENTS. AT THE TIME OF THIS REPORT, THE PATIENTS OUTCOME AND ACTION TAKEN WITH PD THERAPY WERE NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786729 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MINICAP TRANSFER SET