MAUDE Adverse Event Report: CARDINAL HEALTH UMBILICAL CATHETER SINGLE LUMEN 5FR; CATHETER, UMBILICAL ARTERY

Model Number	8888160341
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the rn was attempting to remove the uvc catheter that was placed at 10cm.The dressing was removed, and the sutures were loosened with use of the tweezers and scissors in the suture kit.The rn stabilized the base of the cord with the left hand and used the tweezers from the suture kit to begin removing the catheter slowly with the right hand.The catheter came out easily until the 6.5cm mark.The line then broke off suddenly.Minimal tension had been used while removing this line.The line was sticking out of the umbilicus.The rn quickly clamped the line with the same hand used to stabilize the base, and then called the charge rn for assistance.The base of the line was clamped.They then removed the remainder of the line with assist from the resource rn.The catheter was complete for a total of 10cm.Homeostasis within normal time frame and gauze dressing was applied to the site.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review showed the lot was manufactured according to standards and that there were no discrepancies that could be related to the event reported.The actual sample involved in the reported incident was not returned for evaluation.No additional information, pictures or videos were received.No actions are required at this time as the defect cannot be confirmed as manufacturing related.It was not possible to determine a root cause.If a sample is returned in the future, this complaint will be reopened.This complaint will be used for tracking and trending purposes.

• Brand Name: UMBILICAL CATHETER SINGLE LUMEN 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: 19267584
• Report Number: 3009211636-2024-00810
• Device Sequence Number: 15190847
• Product Code: FOS
• UDI-Device Identifier: 20884527005120
• UDI-Public: 20884527005120
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2024

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: 8888160341
• Device Catalogue Number: 8888160341
• Device Lot Number: 2324100222
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 06/04/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 2 KG