BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK CONTINU-FLO SOLUTION SET

    MDR report key: 15406811 · Received September 12, 2022

    Report

    Report Number
    1416980-2022-04756
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Date of Event
    August 3, 2022
    Report Date
    October 13, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    UDI-DI
    00085412073965
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE MANUFACTURER ADDRESS 1:(B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D4: EXPIRATION DATE. D4: THE CORRECT EXPIRATION DATE IS JANUARY 2027, PREVIOUSLY SUBMITTED AS JANUARY 03, 2027. H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED TO THE PHOTOGRAPH USING THE NAKED EYE WHICH OBSERVED THAT THE TUBING WAS SEPARATED FROM THE SECOND Y-SITE CLEARLINK IN THE DOWNSTREAM PART. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING OF A CLEARLINK, CONTINU-FLO SOLUTION SET DISCONNECTED FROM THE LUER ACTIVATED VALVE WHICH RESULTED IN A LEAK. THIS ISSUE WAS IDENTIFIED DURING PATIENT INFUSION. 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
    2533513 CLEARLINK CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION NA R22B07031 00085412073965

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NI.