MAUDE Adverse Event Report: FOOTPRINT MEDICAL INC. 3.5 FR POLYURETHANE UMBILICAL CATHETER; CATHETER, UMBILICAL ARTERY

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2023

Event Type  malfunction  

Event Description

After catheter aspirated, flushed, and infusing fluids without leaking or complication, it was noted to be broken about halfway up length of catheter.

• Brand Name: 3.5 FR POLYURETHANE UMBILICAL CATHETER
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): FOOTPRINT MEDICAL INC.; 5823 sebastian place; san antonio TX 78249
• MDR Report Key: 16983322
• MDR Text Key: 315759694
• Report Number: 16983322
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 05/16/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other