BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 19484970 · Received June 7, 2024

    Report

    Report Number
    1416980-2024-02786
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 8, 2024
    Report Date
    July 11, 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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION D1, D3, D4, G4. 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 (B)(4). G4: COMBINATION PRODUCT: ADD NO (PREVIOUSLY BLANK). ADDITIONAL INFORMATION WAS ADDED TO D9, H3, H6 AND H11. 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. 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

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MINICAP TRANSFER SET HAD A CONNECTION ISSUE; FURTHER DESCRIBED AS "THE DARK BLUE BODY OF THE TRANSFER SET KEEP SPINNING AND WOULD NOT CONNECT." THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP OF 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
    1423894 MINICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER INTERNATIONAL INC. NA H24B02038 00085412007731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown