BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGYLE

    MDR report key: 25005507 · Received April 27, 2026

    Report

    Report Number
    1423537-2026-00117
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 17, 2026
    Report Date
    April 27, 2026
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    FOZ
    UDI-DI
    10192253040234
    PMA / PMN Number
    K132567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE CARDINAL ARGYLE DOUBLE LUMEN PICC CRACKED IN THE NICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055380 ARGYLE CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ CARDINAL HEALTH 200, LLC 43304 5290982 10192253040234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown