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

Model Number S1UVC-3540

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/28/2022

Event Type  malfunction  

Event Description

Silicone umbilical catheter broke in two places after nurse was readjusting the lines in the bed after the line became taut.All pieces of the catheter were obtained.

Event Description

Silicone umbilical catheter broke in two places after nurse was readjusting the lines in the bed after the line became taut.All pieces of the catheter were obtained.

• 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: 14073329
• MDR Text Key: 288989168
• Report Number: 14073329
• 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: Male