BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 19594135 · Received June 24, 2024

    Report

    Report Number
    1416980-2024-03123
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Report Date
    July 25, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    KDJ
    UDI-DI
    00085412007731
    PMA / PMN Number
    K152675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION D3 AND G4. D3: DEVICE MANUFACTURER NAME: REPLACE BAXTER HEALTHCARE CORPORATION WITH BAXTER INTERNATIONAL INC. G4: COMBINATION PRODUCT: ADD NO (PREVIOUSLY BLANK) ADDITIONAL INFORMATION: H3, H6 AND H11. H11: THE DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WITH THE NAKED EYE IDENTIFIED A SEPARATION BETWEEN THE FEMALE CONNECTOR AND MAIN BODY OF THE TWIST CLAMP. 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 DETERMINED TO BE MANUFACTURING RELATED ISSUE DUE TO AN INADEQUATE SOLVENT BOND BETWEEN THE FEMALE CONNECTOR, INSERT CHIP, AND MAIN BODY. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED 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 ADDRESS: (B)(6). 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 OF THE MINICAP TRANSFER SET; FURTHER DESCRIBED AS, "THE TRANSFER SET NAVY BLUE PART WAS LOOSE." THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP OF 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
    2182058 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER INTERNATIONAL INC. NA H23G10049 00085412007731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown