BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 19624743 · Received June 27, 2024

    Report

    Report Number
    1416980-2024-03249
    Event Type
    Malfunction
    Date Received
    June 27, 2024
    Date of Event
    May 23, 2024
    Report Date
    August 2, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    KDJ
    UDI-DI
    00085412007748
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D3: DEVICE MANUFACTURER NAME: REPLACE BAXTER HEALTHCARE CORPORATION WITH BAXTER INTERNATIONAL INC. G4: COMBINATION PRODUCT: ADD NO (PREVIOUSLY BLANK). H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; 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 D9, H3, H6 AND H11. H11: ONE ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED WITH THE NAKED EYE WHICH OBSERVED A SEPARATION BETWEEN THE DARK BLUE FEMALE CONNECTOR AND THE LIGHT MAIN BODY OF THE TWIST CLAMP ON THE TRANSFER SET. FUNCTIONAL TESTS WERE PERFORMED WHICH INCLUDED LEAK TEST, CLEAR PASSAGE, AND CLAMP FUNCTION TESTS. THERE WERE NO ISSUES OBSERVED DURING THE FUNCTIONAL TESTS PERFORMED, HOWEVER, THE SAMPLE DID NOT MEET SPECIFICATION DUE TO THE SEPARATION. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE MANUFACTURING RELATED DUE TO AN INADEQUATE SOLVENT BOND BETWEEN THE FEMALE CONNECTOR, INSERT CHIP, AND MAIN BODY. THERE WERE NO OTHER ISSUES NOTED DURING THE EVALUATION. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    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 (DARK BLUE) AND THE MAIN BODY OF THE MINICAP TRANSFER SET. THE EVENT WAS FURTHER DESCRIBED AS ¿THE DARK BLUE CONNECTION POINT OF THE TRANSFER SET IS UNSCREWING FROM ITS HOUSING." THIS OCCURRED WHEN DISCONNECTING FROM THE CYCLER AFTER PERITONEAL DIALYSIS THERAPY. THE PATIENT CUT THE LINE TO DISCONNECT FROM THE CYCLER. 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
    479719 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER INTERNATIONAL INC. NA H23K20066 00085412007748

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CASSETTE| CYCLER