MAUDE Adverse Event Report: UTAH MEDICAL PRODUCTS, INC. UTAH MEDICAL UMBILI-CATH. 3.5FR DUAL LUMEN SILICONE UMBILICAL CATHETER; CATHETER, UMBILICAL ARTERY

Lot Number 121261

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/21/2021

Event Type  Injury  

Event Description

Uvc line snapped with minimal to no pulling pressure to the line.Utah medical umbili-cath.3.5 fr dual lumen silicone umbilical catheter ref 4273505, lot 1212617.Fda safety report id# (b)(4).

• Brand Name: UTAH MEDICAL UMBILI-CATH. 3.5FR DUAL LUMEN SILICONE UMBILICAL CATHETER
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC.
• MDR Report Key: 13111635
• MDR Text Key: 282989168
• Report Number: MW5106336
• 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: 12/24/2021

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 Operator: Health Professional
• Device Lot Number: 121261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 DA
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American