BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    MDR report key: 10613171 · Received October 1, 2020

    Report

    Report Number
    1416980-2020-06115
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Report Date
    November 12, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    B5: THE AFFECTED PRODUCT IS CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET, PREVIOUSLY SUBMITTED AS UNSPECIFIED BAXTER TUBING. D1: BRAND NAME: CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET, PREVIOUSLY SUBMITTED AS ¿NI¿. D4: CATALOGUE#: 2C8541, PREVIOUSLY SUBMITTED AS ¿ASKU¿. G1: THE DEVICE MANUFACTURES INFORMATION IS BAXTER HEALTHCARE ¿ CARTAGO, PREVIOUSLY SUBMITTED AS BAXTER HEALTHCARE CORPORATION. G1: DEVICE MANUFACTURER ADDRESS 1: (B)(6). G5: PMA/510K #: K961225 PREVIOUSLY SUBMITTED AS ¿NI¿. H10: TWO (2) ACTUAL SAMPLES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED IN ALL SAMPLES USING THE NAKED EYE WHICH OBSERVED A CRACKED WHITE PORT OF THE CHECK VALVE IN THE FIRST SAMPLE AND SECOND SAMPLE HAD A CRACKED TUBING AND MALE LUER. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DUE TO A MANUFACTURING ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BAXTER TUBING WAS LEAKING FROM AN UNSPECIFIED LOCATION. THE PROCESS STEP IN WHICH THE ISSUE WAS IDENTIFIED WAS NOT REPORTED. 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
    1082552 CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1