BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 19645458 · Received July 1, 2024

    Report

    Report Number
    1416980-2024-03316
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    March 29, 2024
    Report Date
    December 4, 2024
    Manufacturer
    BAXTER INTERNATIONAL INC.
    Product Code
    KDJ
    UDI-DI
    00085412007731
    PMA / PMN Number
    K152675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; 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: D3, D9, G4, H3, H6 AND H11. 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 DETERMINED TO BE MANUFACTURING RELATED ISSUE DUE TO INADEQUATE SOLVENT TO THE INSERT CHIP. A NONCONFORMANCE HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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 TIP COMES OUT OF THE TRANSFER SET¿. THIS WAS OBSERVED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS 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
    545118 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER INTERNATIONAL INC. NA ASKU 00085412007731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female