BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 19538222 · Received June 14, 2024

    Report

    Report Number
    1416980-2024-02915
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    April 17, 2024
    Report Date
    July 24, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    KDJ
    UDI-DI
    00085412007748
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WITH THE NAKED EYE NOTED A SEPARATION BETWEEN THE DARK BLUE FEMALE CONNECTOR AND THE LIGHT BLUE MAIN BODY. FUNCTIONAL TESTING INCLUDING LEAK, CLEAR PASSAGE, AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS RELATED TO INADEQUATE SOLVENT APPLICATION BETWEEN THE FEMALE CONNECTOR, INSERT CHIP, AND MAIN BODY DURING THE MANUFACTURING PROCESS. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER PHONE NO. (B)(6). 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 THE MINICAP TRANSFER SET; FURTHER DESCRIBED AS "STERILE BLUE TIP UNSCREWED FROM LIGHT BLUE SECTION." THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS (PD) 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
    395063 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER INTERNATIONAL INC. NA H23J23062 00085412007748

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown