BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 19436210 · Received May 31, 2024

    Report

    Report Number
    1416980-2024-02639
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Date of Event
    April 11, 2024
    Report Date
    July 8, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC
    Product Code
    KDJ
    UDI-DI
    00085412007731
    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

    D1: BRAND NAME: REPLACE MINICAP TRANSFER SET WITH MINICAP. D3: DEVICE MANUFACTURER NAME: REPLACE BAXTER HEALTHCARE CORPORATION WITH BAXTER INTERNATIONAL INC. D4: UNIQUE IDENTIFIER (UDI) #: REPLACE NI WITH (B)(4); THE LOT NUMBER IS UNKNOWN, THEREFORE, ONLY A PRIMARY DI NUMBER COULD BE PROVIDED. 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 THAT THERE WAS A SEPARATION BETWEEN THE FEMALE CONNECTOR (DARK BLUE) AND THE MAIN BODY (LIGHT BLUE) OF THE MINICAP TRANSFER SET; FURTHER DESCRIBED AS ¿SEPARATION OF DARK BLUE CONNECTOR FROM TWIST CLAMP¿. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THE TRANSFER SET WAS REPLACED. 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
    329223 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER INTERNATIONAL INC NA ASKU 00085412007731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown