MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	8888256503
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	06/30/2025
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 they were having issues with the replogle blocking and leaking from the piggy tail.Per customer, the product has been leaking causing patient impact of having to replace daily and sometimes several times per day.It was flushed with air, but it¿s like the valve was broken, secretions kept coming out of the tail resulting in improper stomach decompression and patient vomiting.
Event or Problem Description
The customer reported that they were having issues with the replogle blocking and leaking from the piggy tail.Per customer, the product has been leaking causing patient impact of having to replace daily and sometimes several times per day.It was flushed with air, but it¿s like the valve was broken, secretions kept coming out of the tail resulting in improper stomach decompression and patient vomiting.Additional information was received from the customer and stated that there was no medical intervention or treatment required.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information.Section h6 health effect: impact code has been updated from 4648 insufficient information to 2199 no health consequences or impact.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.There were no samples returned for evaluation; therefore, the affected device could not be evaluated to confirm the reported failure mode.As such, a root cause could not be determined at this time.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: ARGYLE
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• 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: 22489716
• Report Number: 1423537-2025-00283
• Device Sequence Number: 8016629
• Product Code: BSY
• UDI-Device Identifier: 10884527006427
• UDI-Public: (01)10884527006427(17)261130(10)2134003564
• 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,Followup
• Report Date (Section B): 08/27/2025

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: 8888256503
• Device Catalogue Number: 8888256503
• Device Lot Number: 2134003564
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/12/2025
• Supplement Report FDA Received Date: 07/14/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown