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

Model Number	43303
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) for lot 2303100281 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.
Event or Problem Description
The customer reported that extravasation was observed at the catheter connection with the butterfly valve.The catheter remained in the patient for 7 days.There was no harm reported.
Additional Manufacturer Narrative
Checked g2 report source 'foreign'.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2303100281 was 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: 23069362
• Report Number: 1423537-2025-00369
• Device Sequence Number: 18562248
• Product Code: LJS
• UDI-Device Identifier: 10884527004645
• UDI-Public: (01)10884527004645(17)280111(10)2303100281
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K132567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2025

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: 43303
• Device Catalogue Number: 43303
• Device Lot Number: 2303100281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 09/25/2025; 10/23/2025
• 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