MAUDE Adverse Event Report: FOOTPRINT MEDICAL, INC. 3.5 FRENCH SINGLE LUMEN SILICONE UMBILICAL CATHETER; CATHETER, UMBILICAL ARTERY

Model Number	S1UVC-3540
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Newborn patient in neonate intensive care unit (nicu) isolette moving about vigorously.When registered nurse (rn) settled baby and changed his diaper, his 3.5 umbilical catheter broke about 1.5 to 2 inches after the total parenteral nutrition (tpn) filter or about 2-3 inches from the insertion site.No harm to patient noted.All catheters with same lot number were tested and broke very easily.Removed by supply chain.Manufacturer response for catheter, umbilical artery, na (per site reporter): unknown at this time.

• Brand Name: 3.5 FRENCH SINGLE LUMEN SILICONE UMBILICAL CATHETER
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): FOOTPRINT MEDICAL, INC.; 5823 sebastian place; san antonio TX 78249
• MDR Report Key: 19483216
• Report Number: 19483216
• Device Sequence Number: 20840546
• Product Code: FOS
• UDI-Device Identifier: 00858778006324
• UDI-Public: (01)00858778006324
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/07/2024
• Report Date (Section F): 02/07/2024

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: S1UVC-3540
• Device Lot Number: 220096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2024
• 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: 3 DA
• Patient Sex: Male
• Patient Weight: 2 KG
• Patient Race: White
• Date Report Sent to FDA: 02/07/2024