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

Lot Number 221307

Device Problems Migration or Expulsion of Device (1395); Product Quality Problem (1506)

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

Event Date 02/16/2023

Event Type  malfunction  

Event Description

Neonatologist states the footprint umbilical line catheters are "very flimsy" and migrate frequently, "like we have never seen before."there was an x-ray done when the catheter was initially placed and sutured in.Two days later, the line had migrated.The neonatologists have had to change 4-5 babies lines over approximately 1-1/2 weeks.They all start out the same, in a really good position, and then on follow up x-ray are in a different spot with a bend.

• Brand Name: DUAL LUMEN UMBILICAL CATHETER
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): FOOTPRINT MEDICAL, INC.; 5823 sebastian place; san antonio TX 78249
• MDR Report Key: 16477419
• MDR Text Key: 310596521
• Report Number: 16477419
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/24/2023

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 Lot Number: 221307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1