BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGYLE

    MDR report key: 24780598 · Received April 3, 2026

    Report

    Report Number
    1423537-2026-00094
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 2, 2026
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    LJS
    PMA / PMN Number
    K132567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    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 PICC TUBING CLOSEST TO PATIENT LEAKING/CRACKED. THERE WAS NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838872 ARGYLE CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS CARDINAL HEALTH, INC. 43304

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown