MAUDE Adverse Event Report: UTAH MEDICAL PRODUCTS, INC. UTAH MEDICAL CATH UMBILICAL DL PU 5FR; CATHETER, UMBILICAL ARTERY

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Utah medical uvc catheter forming clots at the end (the tip).Fda safety report id # (b)(4).

• Brand Name: UTAH MEDICAL CATH UMBILICAL DL PU 5FR
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC.
• MDR Report Key: 14236372
• MDR Text Key: 290390106
• Report Number: MW5109413
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1