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

Model Number	43304
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the catheters broke.Additional information received on 01aug2025 stated that the line was placed on (b)(6) 2025 and broke on the (b)(6) 2025; it had a hole in the primary lumen at the transition point where the catheter gets smaller below the female end.This occurred during patient use/line infusing.The line was removed and replaced with a single lumen picc.Labs monitored closely.No hypoglycemia or electrolyte imbalance during this time.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2425400115 was reviewed and no anomalies related to the reported issue were observed.The device was received for evaluation and visual inspection showed signs of use, and a cut in the catheter was observed near the end of the hub, causing the leak.Based on the information provided, it was determined that the most probable cause of the reported defect is that the catheter was damaged during use.The instructions for use outline the correct way to use the catheter and how to avoid the type of damage observed on the device.Per instruction of use, catheter should not be pinched or bent back to temporarily occlude the catheter, since it increases stress on the catheter or pigtail which can lead to a leak or break.Based on this information, no corrective actions are warranted at this time.This information will be used for tracking and trending purposes, and we will continue to monitor.

• 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: 22864919
• Report Number: 1423537-2025-00339
• Device Sequence Number: 20738837
• Product Code: LJS
• UDI-Device Identifier: 10884527004652
• UDI-Public: (01)10884527004652(17)290810(10)2425400115
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/10/2025

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: 43304
• Device Catalogue Number: 43304
• Device Lot Number: 2425400115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/11/2025
• 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