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	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: when attempting to use suction during resuscitation after delivery of a baby, the suction catheter was found broken where the catheter meets the plastic thumb port portion.According to the report, there was no serious harm reported.
Additional Manufacturer Narrative
Based on the information available to us, we were able to confirm the event, and determined that: the device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer.A physical sample was received for evaluation.During the product evaluation, a cut was observed at the valve inlet, where the tube connects.The condition of a broken valve is confirmed; however, it was not confirmed to be related to a manufacturing issue the current process and controls, including subassemblies, finished product assembly, packaging, and product inspections met specifications.During the process review, controls were identified in the production area that prevent the release of nonconforming products.All information received will be used for further tracking and trending purposes.If more information is received at a later date, the investigation will be reopened, and the investigation will be updated accordingly.

• 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: 23310103
• Report Number: 1423537-2025-00411
• Device Sequence Number: 4851821
• Product Code: JOL
• UDI-Device Identifier: 10192253041989
• UDI-Public: 0110192253041989102510500964
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: 31000
• Device Catalogue Number: 31000-
• Device Lot Number: 2510500964
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 12/23/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown