BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGYLE

    MDR report key: 24772444 · Received April 2, 2026

    Report

    Report Number
    1423537-2026-00096
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 6, 2026
    Report Date
    May 14, 2026
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    LJS
    UDI-DI
    10884527004645
    PMA / PMN Number
    K132567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THE PHYSICAL DEVICE WAS RECEIVED FOR EVALUATION, AND THE REPORTED CONDITION WAS OBSERVED; HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THIS INFORMATION, NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME. WE WILL CONTINUE TO TRACK AND TREND THROUGH OUR MONITORING PROGRAMS AND TAKE ACTIONS AS APPLICABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED LEAKAGE FROM THE PICC EXTERNAL TUBING, LOCATED BELOW THE HUB AND ABOVE THE WINGS. THERE WAS NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542065 ARGYLE CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS CARDINAL HEALTH, INC. 43303 10884527004645

    Patients

    Seq Age Sex Outcome Treatment
    1