BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAPS

    MDR report key: 17852300 · Received October 2, 2023

    Report

    Report Number
    1416980-2023-04956
    Event Type
    Injury
    Date Received
    October 2, 2023
    Report Date
    October 26, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    K152129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE ¿ THIS EVENT OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2023. D4: LOT # - AN UNSPECIFIED LOT OF MINICAPS INVOLVED IN RECALL FA-2023-003. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    D4: SUSPECT LOT # - GD912204, GD911764, GD912068, GD911658, GD911825, AND GD912051 H4: DEVICE MANUFACTURE DATE - THE MANUFACTURING DATE RANGES FOR THE SUSPECT LOT NUMBERS WERE AS FOLLOWS: MINICAP BATCH GD912204 (CODE 5C4466P) WAS MANUFACTURED FROM 11/04/22 TO 11/11/22. MINICAP BATCH GD911764 (CODE 5C4466P) WAS MANUFACTURED FROM 07/22/22 TO 08/02/22. MINICAP BATCH GD912068 (CODE 5C4466P) WAS MANUFACTURED FROM 11/04/22 TO 11/11/22. MINICAP BATCH GD911658 (CODE 5C4466P) WAS MANUFACTURED FROM 06/22/22 TO 06/28/22. MINICAP BATCH GD911825 (CODE 5C4466P) WAS MANUFACTURED FROM 08/11/22 TO 08/18/22. MINICAP BATCH GD912051 (CODE 5C4466P) WAS MANUFACTURED FROM 09/30/22 TO 10/07/22. H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, COMPANION SAMPLES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. ADDITIONALLY, THE POUCHES WERE OPENED TO VERIFY PRESENCE OF IODINE, AND THERE WERE NO ISSUES NOTED. FUNCTIONAL PRESSURE TESTING WAS PERFORMED ON THE RETURNED SAMPLES TO ENSURE SEAL INTEGRITY, AND THERE WERE NO FAILURES OBSERVED. THER REPORTED CONDITION WAS NOT VERIFIED. THE COMPANION SAMPLES WERE CONFORMING PRODUCT. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THE SUSPECT LOTS. 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. IT WAS REPORTED THAT THE PATIENT USED UNSPECIFIED RECALLED MINICAPS; HOWEVER, THERE WERE NO ISSUES OBSERVED WITH THE MINICAPS DURING THERAPY THAT WOULD HAVE CAUSED PERITONITIS, THEREFORE, THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR PERITONITIS AND WAS TREATED WITH UNSPECIFIED ANTIBIOTICS. NINE DAYS AFTER BEING ADMITTED, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. APPROXIMATELY A MONTH AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT STOPPED ANTIBIOTIC TREATMENT AND RECOVERED FROM PERITONITIS. WHILE THE PATIENT HAD BEEN HOSPITALIZED FOR PERITONITIS, THE PATIENT¿S CATHETER WAS REMOVED, AND THE PATIENT WAS PLACED ON HEMODIALYSIS. THE PATIENT PERFORMED HEMODIALYSIS FOR APPROXIMATELY FOUR MONTHS. AT THE TIME OF THIS REPORT, THE PATIENT WAS PERFORMING PD THERAPY AGAIN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003234 MINICAPS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H