BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 19575876 · Received June 20, 2024

    Report

    Report Number
    1416980-2024-03077
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    May 26, 2024
    Report Date
    July 26, 2024
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    UDI-DI
    00085412007748
    PMA / PMN Number
    K192705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    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 FEMALE CONNECTOR AND 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR (DARK BLUE) AND THE MAIN BODY (LIGHT BLUE) OF THE TWIST CLAMP ON A MINICAP TRANSFER SET. THE DARK BLUE CONNECTOR ON THE TRANSFER SET STARTED COMING UNSCREWED. THIS WAS OBSERVED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS (PD) THERAPY, AS THE HOME PATIENT (HP) WAS DISCONNECTING FROM TREATMENT. THE TRANSFER SET WAS REPLACED TO RESOLVE THE ISSUE. 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
    2173160 MINICAP BAXTER INTERNATIONAL INC. KDJ BAXTER HEALTHCARE CORPORATION NA ASKU 00085412007748

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown