MAUDE Adverse Event Report: CARDINAL HEALTH UMBILICAL CATHETER SNGL LUMEN 3.5FR; CATHETER, UMBILICAL ARTERY

Model Number	8888160333
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
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 that on (b)(6) 2024 a 3.5 fr umbilical catheter was placed by sterile technique in an umbilical artery and sutured in place.The catheter was inserted up to the 13cm mark.On (b)(6) 2024 the catheter was removed by the bedside rn, sutures removed prior to removal.During removal, the catheter had a clean break at approximately the 9.25 cm mark.The rn had a sterile hemostat available and was able to attach to the remaining catheter and remove the remainder from the umbilicus.No harm was done.The rn reported the removal process went smoothly prior to the break, no increase in tension when removing the line.On 11mar2024 the initial reporter stated that the catheter broke into two separate pieces which the nurse was able to see at all times during the time it was broken then removed.The rn reported the removal was the same as far as the removal of other umbilical lines.No further treatment required.The customer confirmed it was a standard removal due to the order to discontinue the line.
Additional Manufacturer Narrative
Based on the information available to us, we were able to confirm the event and determined that: the returned device was broken between points 10 and 9.No other damage was noted.Based on available information and review of the process, controls and documentation, an exact root cause could not be identified.All information received will be used for further tracking and trending purposes.

• Brand Name: UMBILICAL CATHETER SNGL LUMEN 3.5FR
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18937249
• Report Number: 3009211636-2024-00802
• Device Sequence Number: 12455002
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: 20884527005113
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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): 07/31/2024

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
• Operator of Device: Health Professional
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 07/31/2024
• 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