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

Model Number	8888509703
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the edge of the suction tube was missing.Additional information was received from the customer and stated that at the customer end, they opened the individual package for use.During use, they noticed that a part was missing.They checked the package for any missing part left, however, there was no part inside the package.Hence, it is considered the product was initially missing a part and packed as incomplete.The issue was noticed during operation; there was no patient injury reported.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2306208964 was reviewed and no anomalies related to the reported issue were observed.Two devices were received for evaluation and the reported condition was observed in one of the received samples.A definitive root cause could not be determined.Based on this information, no corrective actions are warranted at this time.Manufacturing personnel were notified of this complaint for awareness and all information received will be used for tracking and trending purposes.

• 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, INC.; 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: 21258003
• Report Number: 1423537-2025-00053
• Device Sequence Number: 8243465
• Product Code: JOL
• UDI-Device Identifier: 10884527019731
• UDI-Public: (01)10884527019731(17)280229(10)2306208964
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/24/2025

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: 8888509703
• Device Catalogue Number: 8888509703
• Device Lot Number: 2306208964
• 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: 01/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 02/24/2025
• 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
• Patient Sex: Unknown