MAUDE Adverse Event Report: FOOTPRINT MEDICAL, INC.; CATHETER, UMBILICAL ARTERY

Model Number	P2UVC3.5
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This nurse went to taped uvc [umbilical venous catheter] to infant's abdomen and noticed the uvc was not intact/appears cracked.Fluids were not infusing yet, no blood/fluid was coming out of crack.

• Brand Name: NA
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): FOOTPRINT MEDICAL, INC.; 5823 sebastian place; san antonio TX 78249
• MDR Report Key: 23050430
• Report Number: 23050430
• Device Sequence Number: 15830751
• Product Code: FOS
• UDI-Device Identifier: 00858778006539
• UDI-Public: (01)00858778006539
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2025
• Report Date (Section F): 09/02/2025

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: P2UVC3.5
• Device Lot Number: 250254
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/02/2025