BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK/CONTINU-FLO/DUO-VENT

    MDR report key: 22570241 · Received July 22, 2025

    Report

    Report Number
    1416980-2025-03858
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    June 24, 2025
    Report Date
    August 22, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K203609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION ADDED TO H6. CORRECTION TO H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. THE RETURNED PHOTOGRAPH WAS REVIEWED, AND THE REPORTED LEAK COULD NOT BE IDENTIFIED. THE REPORTED CONDITION WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    D4: LOT #: CUSTOMER PROVIDED A SUSPECT LOT# R25A13048. D4: EXPIRATION DATE (SUSPECT LOT): 01/13/2027. D4: UNIQUE IDENTIFIER (UDI) # (SUSPECT LOT): (B)(4). H4: THE LOT WAS MANUFACTURED ON 1/14/2025. D4: LOT #: CUSTOMER PROVIDED ANOTHER SUSPECT LOT# R25C29130. D4: EXPIRATION DATE (SUSPECT LOT): 03/30/2027. D4: UNIQUE IDENTIFIER (UDI) # (SUSPECT LOT): (B)(4). H4: THE LOT WAS MANUFACTURED ON 3/30/2025. THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND A LEAK IN THE Y-SITE CLEARLINK WAS OBSERVED. 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 POTENTIAL LOTS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET LEAKED FROM THE Y-SITE. THE ISSUE WAS FURTHER DESCRIBED AS IT APPEARED THAT THE SET LEAKED DOXIL FROM THE PART THAT IS GLUED/INSERTED. 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
    943930 CLEARLINK/CONTINU-FLO/DUO-VENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION 2C8541 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DOXIL.