MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	43304
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d2a product code(additional code): foz.An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the product experienced leakage, which required removal and escalated intervention to place a picc line.Additional information received from the customer indicated that the device was placed on (b)(6) 2026.On (b)(6) 2026, the picc was found to be leaking at the hub (the purple wing that connects to the white part of the picc).As a result, the infant had a midline placed the following day.According to the customer, the patient experienced additional painful iv sticks and an increased risk of infection due to the unnecessary attempts.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2430400161 were reviewed and no anomalies related to the reported issue were 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.

• Brand Name: ARGYLE
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 24329385
• Report Number: 1423537-2026-00036
• Device Sequence Number: 21275463
• Product Code: LJS
• UDI-Device Identifier: 10884527004652
• UDI-Public: (01)10884527004652(17)291114(10)2430400161
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K132567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 43304
• Device Catalogue Number: 43304
• Device Lot Number: 2430400161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown