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

Model Number S1UVC-3540

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

Registered nurse (rn) was removing a 3.5fr single lumen silicone umbilical catheter, and upon gently removing catheter, the catheter broke at the suture line.Pressure was applied by rn, md notified immediately.Md arrived at bedside and was able to grab the rest of the catheter at the umbilicus and able to remove the rest of the catheter.Catheter length was verified by rn twice.Pressure applied by md and rn until bleeding stopped.

Event Description

Registered nurse (rn) was removing a 3.5fr single lumen silicone umbilical catheter, and upon gently removing catheter, the catheter broke at the suture line.Pressure was applied by rn, md notified immediately.Md arrived at bedside and was able to grab the rest of the catheter at the umbilicus and able to remove the rest of the catheter.Catheter length was verified by rn twice.Pressure applied by md and rn until bleeding stopped.

• Brand Name: NA
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): FOOTPRINT MEDICAL, INC.; 5823 sebastian place; san antonio TX 78249
• MDR Report Key: 14073330
• MDR Text Key: 289000057
• Report Number: 14073330
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

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 Catalogue Number: S1UVC-3540
• Device Lot Number: 201467
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/04/2022
• Date Report to Manufacturer: 04/11/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female