BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERLINK

    MDR report key: 20662185 · Received November 12, 2024

    Report

    Report Number
    1416980-2024-06466
    Event Type
    Injury
    Date Received
    November 12, 2024
    Date of Event
    September 12, 2024
    Report Date
    January 16, 2025
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K921899
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: 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

    D4: LOT #: REPORTED NON-VALID LOT NUMBERS: 8900-0223-01 AND 8900-000219-0. D4: UNIQUE IDENTIFIER (UDI) #: THE LOT NUMBER (10) IS UNKNOWN; THEREFORE, THE UDI NUMBER ONLY WILL CONTAIN THE DEVICE IDENTIFIER (01). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN INTERLINK SYSTEM NON-DEHP T-CONNECTOR EXTENSION SET LEAKED. DURING AN UNSPECIFIED INFUSION THE PATIENT BECAME AGITATED, AND THE T-CONNECTOR STARTED BLEEDING BACK INTO THE LINE. THEN BLOOD WAS OBSERVED IN THE NON-BAXTER TRANSPARENT LINE GUARD. THE NURSE NOTED ALL CONNECTIONS WERE TIGHT. THE LINE WAS IMMEDIATELY CLAMPED PROXIMALLY TO THE LEAK AND FLUIDS WERE STOPPED TO PREVENT SIGNIFICANT BLOOD LOSS. A NEW T-CONNECTOR WAS THEN STERILELY PLACED. THE VOLUME OF BLOOD LOSS WAS NOT REPORTED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1539802 INTERLINK SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE CORPORATION 2N3339 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention UNSPECIFIED SOLUTION| VALGAURD