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

Model Number S1UVC-3540

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 10/09/2022

Event Type  malfunction  

Event Description

A 3.5 uac placed in infant xray and obtained cath not in position.Gentle pressure applied per nnp to pull back into position and cath snapped.Pressure held and remaining piece removed intact.

• Brand Name: SILICONE UMBILICAL CATHETER
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): FOOTPRINT MEDICAL INC.; san antonio TX 78249
• MDR Report Key: 16453419
• MDR Text Key: 310549031
• Report Number: MW5115278
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2022
• Device Model Number: S1UVC-3540
• Device Lot Number: 201467
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 2 KG