MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; CATHETER AND TIP, SUCTION

Model Number	8888570549
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that argyle chest tube fracturing inside patient.Additional information received stating the patient had to have an additional procedure to have the remaining part of the tube removed.
Additional Manufacturer Narrative
The device history record review could not be performed since no lot number was provided.Few pictures were provided for analysis, and upon reviewing the pictures, the reported issue was observed.The physical device was not returned for evaluation.A definitive root cause could not be determined.Based on this information, no corrective actions are warranted at this time.We will continue to monitor reports and take actions as applicable.

• Brand Name: ARGYLE
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 22905507
• Report Number: 1423537-2025-00350
• Device Sequence Number: 7932860
• Product Code: JOL
• UDI-Device Identifier: 10884521050846
• UDI-Public: (01)10884521050846
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 09/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888570549
• Device Catalogue Number: 8888570549
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 09/30/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown