MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC ARGYLE; CATHETER AND TIP, SUCTION

Model Number	31000-
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
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 the suction catheter top snapped off when patient was having desats.There was no patient harm.
Additional Manufacturer Narrative
One used device was received for investigation.The device was evaluated and the reported condition was observed; the sample exhibited a fracture at the junction where the tube connects to the valve.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to this condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A gemba inspection was carried out throughout the entire manufacturing process, verifying compliance with all processes and controls, including subassemblies, finished product assembly, packaging, and product inspections.Additionally, product quality control inspections were conducted for material release, and production staff performed a full visual inspection during the packaging process to detect and discard any defects.An attempt was made to reproduce the observed condition, and the only way to generate the condition was through applying external force in the component section.Based on all available information, a definitive root cause could not be determined at this time.The appropriate personnel has been notified of this complaint for awareness purposes.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: ARGYLE
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 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: 24662504
• Report Number: 1423537-2026-00079
• Device Sequence Number: 18463957
• Product Code: JOL
• UDI-Device Identifier: 10192253041989
• UDI-Public: (01)10192253041989(10)2329701064
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/28/2026

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: 31000-
• Device Catalogue Number: 31000-
• Device Lot Number: 2329701064
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown