MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; CATHETER, UMBILICAL ARTERY

Model Number	8888160333
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the uac noticed to be short upon removal.An x-ray confirmed the uac retention.A new 3.5fr uac catheter identical to the one used on the patient was tested.It was stretched with significant force to assess fragility.The catheter did not break.The assessment is that the uac dissected upon removal as it was compromised or defective in some way.Additional information was received from the customer and stated that the baby had an umbilical exploration which failed and a beside exploratory laparostomy was performed where the catheter was found and removed.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2318100195 was reviewed and no anomalies related to the reported issue were observed.The device was received for evaluation and visual inspection showed signs of use, and catheter broke was observed.Based on the information provided, it was determined that the most probable cause of the reported issue is that the catheter was damaged during use.The instructions for use outline the correct way to use the catheter and how to avoid the type of breakage observed on the returned device.This information will be used for tracking and trending purposes, and we will continue to monitor.
Additional Manufacturer Narrative
Section h 10 (additional manufacturer narrative): originally reported as "the device history record (dhr) for lot 2318100195 was reviewed and no anomalies related to the reported issue were observed" and should be "the device history record (dhr) for lot 2403100242 was reviewed and no anomalies related to the reported issue were observed".

• Brand Name: ARGYLE
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH, INC.; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21422597
• Report Number: 1423537-2025-00092
• Device Sequence Number: 18120993
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: (01)20884527005113(17)290108(10)2403100242
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 2403100242
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 05/07/2025; 05/28/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown