BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 17916539 · Received October 11, 2023

    Report

    Report Number
    1416980-2023-05177
    Event Type
    Injury
    Date Received
    October 11, 2023
    Report Date
    October 11, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K152129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: NULL VALUE ¿ THIS EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2023. D4: LOT # - THE PATIENT FURTHER ALLEGED THAT THEY HAD BEEN USING MINICAPS ASSOCIATED WITH DEVICE RECALL FA-2023-003. THIS REPORT INVOLVES A PATIENT WHO EXPERIENCED CLOUDY EFFLUENT IN THE CONTEXT OF PERITONEAL DIALYSIS. WHILE THERE WAS NO SPECIFIC INFECTION REPORTED, IT IS CURRENTLY UNABLE TO BE RULED OUT AS A CAUSE FOR THE REPORTED SYMPTOMS. 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 A TWO BACTERIA CLOUDY EFFLUENT. THE CAUSE OF THE CLOUDY EFFLUENT WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THIS EVENT; HOWEVER, THE PATIENT WAS PRESCRIBED UNSPECIFIED ANTIBIOTIC TREATMENT FOR CLOUDY EFFLUENT. AT THE TIME OF THIS REPORT, THE PATIENT 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
    1413858 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention DIANEAL, PD4 2.5%