BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGYLE

    MDR report key: 23352174 · Received October 21, 2025

    Report

    Report Number
    1423537-2025-00426
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    October 11, 2025
    Report Date
    December 11, 2025
    Manufacturer
    CARDINAL HEALTH, INC
    Product Code
    LJS
    UDI-DI
    10884527004645
    PMA / PMN Number
    K132567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 2314900168 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. A DEVICE WAS RECEIVED FOR EVALUATION, AND THE REPORTED CONDITION WAS OBSERVED. THE ROOT CAUSE APPEARS TO BE MISALIGNMENT DURING THE BONDING PROCESS. A QUALITY ALERT HAS BEEN ISSUED, AND MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED FOR AWARENESS. NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME. WE WILL CONTINUE TO TRACK AND TREND THROUGH OUR MONITORING PROGRAMS AND TAKE ACTIONS AS APPLICABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: FOZ. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THEY FOUND THAT THE PICC LINE WAS NOT ATTACHED TO THE FLANGE/HUB. THE LINE WAS SEPARATED. PER CUSTOMER, THUMB WAS PLACED ON THE LINE TO KEEP DEVICE EXTERNAL TO THE PATIENT AND STOPPED THE INFUSIONS. THE ISSUE WAS REPORTED TO THE RESIDENT, ATTENDING, CERTIFIED REGISTERED NURSE (CRN), AND THE PHARMACY. THE CRN PULLED THE PICC AND PLACED THE DEVICE IN A STERILE CONTAINER. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE PICC WAS INSERTED ON (B)(6) 2025, AND THE INCIDENT OCCURRED ON (B)(6) 2025. THERE WAS A DELAY IN TREATMENT AND A NEW PICC WAS INSERTED AS A RESULT. THE PATIENT IS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234737 ARGYLE CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS CARDINAL HEALTH, INC 43303 2314900168 10884527004645

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown