BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTENDED LIFE PD TRNS

    MDR report key: 22419339 · Received July 7, 2025

    Report

    Report Number
    2314912-2025-00720
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Report Date
    July 30, 2025
    Manufacturer
    VANTIVE US HEALTHCARE LLC
    Product Code
    KDJ
    UDI-DI
    00085412841625
    PMA / PMN Number
    K152675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3/D10: THE EVENT OCCURRED BETWEEN THE NIGHT OF 06/082025 AND THE MORNING OF 06/09/2025. D4: THE LOT NUMBER IS UNKNOWN, THEREFORE, ONLY A PRIMARY DI NUMBER COULD BE PROVIDED. H11: 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

    ADDITIONAL INFORMATION B5, D1, D4 (CATALOGUE #, UDE #), D9, G4 (510K #), H3 H6 AND H11. B5: CLARIFICATION WAS RECEIVED FROM THE NURSE STATING THE CORRECT PRODUCT CODE FOR THE ALLEGED TRANSFER SET WAS 5C4482A (NOT 5C4483 AS INITIALLY REPORTED). H11: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND A SEPARATION BETWEEN THE FEMALE CONNECTOR AND THE MAIN BODY WAS OBSERVED. LEAK, CLEAR PASSAGE, AND CLAMP FUNCTION TESTING WERE PERFORMED, AND NO ISSUES WERE OBSERVED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE SEPARATION WAS DETERMINED TO BE MANUFACTURING RELATED DUE TO AN INADEQUATE SOLVENT BOND BETWEEN THE FEMALE CONNECTOR, THE INSERT CHIP, AND THE MAIN BODY. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR AND THE MAIN BODY OF A MINICAP TRANSFER SET. THIS OCCURRED WHILE TRYING TO DISCONNECT FROM THE PATIENT LINE OF AN AMIA CASSETTE AFTER AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10869 MINICAP EXTENDED LIFE PD TRNS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ VANTIVE US HEALTHCARE LLC NA ASKU 00085412841625

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AMIA APD CASSETTE