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

Model Number	8888160333
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: the single lumen uav catheter was faulty.A term infant with severe pphn (persistent pulmonary hypertension of the newborn) requiring uac after admission.The assessment notes: app's attempting to place 3.5fr uac.Catheter was flushed with heparinized normal saline prior to insertion per policy.Catheter was then inserted with positive blood return.When attempting to draw blood samples from the line, blood was able to be drawn back to the fuse and then stopped.App's were unable to draw any additional blood back or flush any hep.Saline forward.The recommendation was to withdraw the line and a new line was placed.The faulty catheter was left in the care of apsm.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition and determine the root cause.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.This complaint will be used for tracking and trending purposes.Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• 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; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20304604
• Report Number: 1423537-2024-00168
• Device Sequence Number: 7726144
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: (01)20884527005113(10)2405900108(17)290201
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: NO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 2405900108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/03/2024
• 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
• Patient Sex: Unknown