BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGYLE

    MDR report key: 24329385 · Received February 12, 2026

    Report

    Report Number
    1423537-2026-00036
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    January 21, 2026
    Report Date
    March 13, 2026
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    LJS
    UDI-DI
    10884527004652
    PMA / PMN Number
    K132567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR LOT 2430400161 WERE REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. THERE WERE NO SAMPLES RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED DEVICE COULD NOT BE EVALUATED TO DETERMINE THE ROOT CAUSE.¿WE WILL CONTINUE TO MONITOR REPORTS AND TAKE ACTIONS AS APPLICABLE.

    Additional Manufacturer Narrative · 0

    SECTION D2A PRODUCT CODE(ADDITIONAL CODE): FOZ. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE PRODUCT EXPERIENCED LEAKAGE, WHICH REQUIRED REMOVAL AND ESCALATED INTERVENTION TO PLACE A PICC LINE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THAT THE DEVICE WAS PLACED ON (B)(6) 2026. ON (B)(6) 2026, THE PICC WAS FOUND TO BE LEAKING AT THE HUB (THE PURPLE WING THAT CONNECTS TO THE WHITE PART OF THE PICC). AS A RESULT, THE INFANT HAD A MIDLINE PLACED THE FOLLOWING DAY. ACCORDING TO THE CUSTOMER, THE PATIENT EXPERIENCED ADDITIONAL PAINFUL IV STICKS AND AN INCREASED RISK OF INFECTION DUE TO THE UNNECESSARY ATTEMPTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390568 ARGYLE CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS CARDINAL HEALTH, INC. 43304 2430400161 10884527004652

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown