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

Model Number	8888256529
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 replogle tube was cut in half in packaging.Upon inspection of other replogle tubes in the unit, another packaging had a cut piece of replogle tube attached to it.There was no harm reported.
Additional Manufacturer Narrative
There were no samples returned for investigation, but a photo was provided.The photo was evaluated, and the reported condition was observed.Based on all available information, a definitive root cause could not be determined at this time.However, actions have been implemented to address the condition observed.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: 22109072
• Report Number: 1423537-2025-00217
• Device Sequence Number: 7276257
• Product Code: BSY
• UDI-Device Identifier: 10884527006410
• UDI-Public: (01)10884527006410(17)290228(10)2406105064
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 08/21/2025

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: 8888256529
• Device Catalogue Number: 8888256529
• Device Lot Number: 2406105064
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown