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

Model Number	8888256503
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
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 they went to replace the replogle suction catheter in the patient.While placing they noticed part of the tube was missing, as if it had been cut out which meant that the tube could not function.They went to grab a replacement tube and in the packaging of the following tube, they found the piece that was missing.
Additional Manufacturer Narrative
The device was received for investigation, and upon evaluation, the reported condition was observed.A review of the device history record confirmed that the product was released in accordance with all quality standards.Despite a thorough analysis, the exact root cause could not be definitively identified.However, a potential root cause was identified, the tube may have been trapped during the sealing process due to improper placement.Actions have been implemented to address the observed condition.All information received will be used for tracking and trending purposes.

• 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: 20845330
• Report Number: 1423537-2024-00330
• Device Sequence Number: 3838618
• Product Code: BSY
• UDI-Device Identifier: 10884527006427
• UDI-Public: (01)10884527006427(17)281231(10)2401904164
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 01/09/2025

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
• Operator of Device: Health Professional
• Device Model Number: 8888256503
• Device Catalogue Number: 8888256503
• Device Lot Number: 2401904164
• 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: 11/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown