BEUDAMED
    FDA Adverse Event Death Summary report: N

    MINICAP WITH POVIDONE-IODINE SOLUTION

    MDR report key: 22809618 · Received August 14, 2025

    Report

    Report Number
    1416980-2025-04192
    Event Type
    Death
    Date Received
    August 14, 2025
    Report Date
    August 14, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDJ
    UDI-DI
    00085412007694
    PMA / PMN Number
    K152129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B3: THE PERITONITIS OCCURRED ON AN UNSPECIFIED DATE IN (B)(6) 2022 D4: THE LOT NUMBER IS UNKNOWN, THEREFORE, ONLY A PRIMARY DI NUMBER COULD BE PROVIDED. 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

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS AND PASSED AWAY AFTER USING MINICAP DISCONNECT CAPS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE CAREGIVER REPORTED, DURING A ROUTINE CHECK AT THE PD FACILITY, THE PATIENT WAS FOUND TO HAVE PERITONITIS. THE PATIENT RECEIVED UNSPECIFIED TREATMENT AT THE FACILITY AND WAS SENT HOME WITH UNSPECIFIED ANTIBIOTICS FOR PERITONITIS. ON THE DRIVE HOME, THE PATIENT FELT ILL AND BEGAN VOMITING. THE CAREGIVER REPORTED THEY CALLED EMERGENCY SERVICES AND SUBSEQUENTLY THE PATIENT WAS TAKEN TO THE HOSPITAL WHERE IT WAS CONFIRMED THE PATIENT HAD PERITONITIS. ACCORDING TO THE REPORTER, "OVER THE NEXT NINE MONTHS" THE PATIENT CONTINUED TO HAVE SEVERE UNSPECIFIED INFECTIONS THAT "REAPPEARED WITHIN THREE TO FOUR WEEKS FOLLOWING EACH TREATMENT". IT WAS REPORTED THAT "THE PATIENT'S CONDITION WORSENED AND REMAINED HOSPITALIZED CONTINUOUSLY". THE PATIENT SUBSEQUENTLY PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS "A RESULT OF PERITONITIS" AND ANOTHER INDICATION. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT PD THERAPY WAS ONGOING PRIOR TO DEATH, HOWEVER IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782531 MINICAP WITH POVIDONE-IODINE SOLUTION SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA NI 00085412007694

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| D| R