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

Model Number	8888160531
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 that the double lumen right atrial (ra) line was cracked.It was cracked after 4 pm rounds after fresh frozen plasma (ffp) were given.Per customer, while inspecting the defective ra line, piece of tegaderm was removed on blue lumen of line to inspect the ¿crack¿, blue lumen then split in 2 pieces.The customer further stated that split/crack was diagonal and appeared like a clean cut potentially.It was not known if the line was accidentally snipped with dressing change or broke from repeated tension at same site.The customer further stated that this was placed in the cvor and the issue was noticed in the ccu.Per customer, the department utilize this dl uvc in the right atrial position which they call ¿ra line".In addition, the line was not replaced after it was pulled.
Additional Manufacturer Narrative
The device history record review could not be performed since no lot number was provided.The device was received for evaluation and visual inspection showed signs of use, and it was observed that the catheter was broken in the blue extension.Based on the information provided, it was determined that the most probable cause of the reported issue is that the catheter was broken during use.The instructions for use outline the correct way to use the catheter and how to avoid the type of break observed on the returned device.This information will be used for tracking and trending purposes, and we will continue to monitor.

• 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: 20267962
• Report Number: 1423537-2024-00159
• Device Sequence Number: 17996928
• Product Code: FOS
• UDI-Device Identifier: 20884527005175
• UDI-Public: 20884527005175
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K941814
• 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): 11/13/2024

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: 8888160531
• Device Catalogue Number: 8888160531
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/13/2024
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown