BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 17758124 · Received September 15, 2023

    Report

    Report Number
    1416980-2023-04673
    Event Type
    Injury
    Date Received
    September 15, 2023
    Report Date
    October 17, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K152129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: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.

    Additional Manufacturer Narrative · 0

    D4: LOT # - AN UNSPECIFIED LOT NUMBER RELATED TO DEVICE RECALL FA-2023-003. F2: UF / IMPORTER REPORT NUMBER - MW5120158 AND MW5120157. 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 PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS EVENT. AT THE TIME OF THE PERITONITIS EVENT THE PATIENT WAS USING THE MINICAPS FROM THE RECALLED BATCHES; HOWEVER, THE PATIENT DID NOT MENTION ANY ISSUES WITH MINICAPS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. ON AN UNSPECIFIED DATE, THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR PERITONITIS. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME AND THE ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039921 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention