MAUDE Adverse Event Report: FOOTPRINT MEDICAL INC. POLYURETHANE UMBILICAL CATHETER, SINGLE LUMEN, 3.5 FR X 30 CM LENGTH

Model Number	P1UVC-3540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not available for examination.The reporting institution information was not available and thus follow up for more information was not possible.In-house investigation included review of device history records.The investigation indicated no evidence of manufacturing or material related issues that would have contributed to the event.
Event or Problem Description
It was reported that upon removal of the catheter, the tip broke off and remained in the umbilicus and intervention was required.The type of intervention performed was not reported.

• Brand Name: POLYURETHANE UMBILICAL CATHETER, SINGLE LUMEN, 3.5 FR X 30 CM LENGTH
• Common Device Name: UMBILICAL CATHETER
• Manufacturer (Section D): FOOTPRINT MEDICAL INC.; 5823 sebastian place; san antonio TX 78249
• Manufacturer (Section G): FOOTPRINT MEDICAL INC.; 5823 sebastian place; san antonio TX 78249
• Manufacturer Contact: robert davis ; 5823 sebastian place; san antonio, TX 78249 ; 2102262600
• MDR Report Key: 23837836
• Report Number: 3007697249-2025-00004
• Device Sequence Number: 5081167
• Product Code: FOS
• UDI-Device Identifier: 00858778006386
• UDI-Public: (01)00858778006386(17)270220(10)250114
• Combination Product (Y/N): N
• PMA/510(K) Number: K120304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: P1UVC-3540
• Device Lot Number: 250114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown