BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGYLE

    MDR report key: 24808843 · Received April 7, 2026

    Report

    Report Number
    1423537-2026-00097
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 3, 2026
    Report Date
    May 14, 2026
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    LJS
    UDI-DI
    10884527004652
    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) REVIEW COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. A PICTURE WAS RECEIVED FOR EVALUATION. UPON REVIEW, THE REPORTED ISSUE WAS NOT 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 DURING STERILE DRESSING CHANGE THE LINE WAS OBSERVED TO BE CRACKED AT CONNECTION OF CATHETER AND HUB. THERE WAS NO HARM REPORTED. PER CUSTOMER, THE PATIENT REQUIRED INSERTION OF ANOTHER BRAND OF PICC LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537057 ARGYLE CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS CARDINAL HEALTH, INC. 43304 10884527004652

    Patients

    Seq Age Sex Outcome Treatment
    1