BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGYLE

    MDR report key: 24484984 · Received March 2, 2026

    Report

    Report Number
    1423537-2026-00050
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    February 5, 2026
    Report Date
    March 31, 2026
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    LJS
    UDI-DI
    10884527004652
    PMA / PMN Number
    K132567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PLEASE DISREGARD THIS REPORT NUMBER 1423537-2026-00050. THE PRODUCT SAMPLE RECEIVED FOR EVALUATION HAS BEEN IDENTIFIED AS NOT ORIGINATING FROM CARDINAL HEALTH. CUSTOMER CONFIRMATION FURTHER VERIFIED THAT THE REPORTED ISSUE DOES NOT INVOLVE THE CARDINAL HEALTH PRODUCT 43304 1.9 FR ARGYLE DUAL LUMEN PICC. IT HAS THEREFORE BEEN DETERMINED THAT THIS COMPLAINT WAS INADVERTENTLY SUBMITTED TO CARDINAL HEALTH. CONSEQUENTLY, THIS COMPLAINT WILL BE FORMALLY CLOSED, AND NO FURTHER ACTION IS REQUIRED FROM CARDINAL HEALTH.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THERE WAS AN ORDER TO PULL THE PICC LINE OUT 1CM. AFTER PREPPING EVERYTHING AS USUAL, THEY REMOVED THE DRESSING WITH NO DIFFICULTY AND PROCEEDED TO PULL BACK THE PICC. AFTER PULLING BACK ON THE LINE JUST PAST THE INSERTION SITE, LIPIDS STARTED POURING OUT OF THE CATHETER. THERE WAS NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150881 ARGYLE CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS CARDINAL HEALTH, INC. 43304 10884527004652

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown