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)
Date of Event	01/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported they think the end of the replogle has snapped off inside the oesophageal pouch of a baby or was not present before placing into the baby.Staff removed the replogle tube, size 8fr, on 12jan2025, from the baby and noted that the tip was missing.It had a jagged end like it had snapped off.The baby has had a number of x-rays but no obvious tip was remaining in the oesophageal pouch.The fragility of the end piece that sits in patient should be looked at as it doesn¿t look as solid as it used to (hence why it has snapped off).
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
One device was received for investigation.The device was inspected, and the reported condition was observed.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.Based on all available information, no conditions were found during manufacturing that could trigger the observed condition.As such, a definitive 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: 21169659
• Report Number: 1423537-2025-00036
• Device Sequence Number: 11825114
• Product Code: BSY
• UDI-Device Identifier: 10884527006410
• UDI-Public: (01)10884527006410(17)281031(10)2333105864
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/20/2025

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: 2333105864
• 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: 01/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown