BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODAN TRIFURCATED EXTENSION SET

    MDR report key: 14371087 · Received May 12, 2022

    Report

    Report Number
    14371087
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    April 11, 2022
    Report Date
    May 3, 2022
    Manufacturer
    CODAN US CORPORATION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    "THE END OF THE TRANSPLANT TURKEY FOOT (TRI-FUSE) TUBING CONNECTOR WAS RETAINED IN PATIENT'S BLUE LUMEN AFTER AUTOLOGOUS TRANSPLANT WAS COMPLETE. CENTRAL LINE WAS DOUBLE-CLAMPED, AND CAPPED. PROVIDER WAS NOTIFIED AND NURSE MANAGER WAS INVOLVED. STERILE ATTEMPTS WERE MADE TO REMOVE PART, BUT WERE UNSUCCESSFUL. PATIENT WAS SENT TO IR TO REPLACE/EXCHANGE LINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041959 CODAN TRIFURCATED EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CODAN US CORPORATION 76837

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown