MAUDE Adverse Event Report:; CATHETER, UMBILICAL ARTERY

Lot Number 1924700105

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 06/03/2020

Event Type  malfunction  

Event Description

Uac inserted by neonatal nurse practitioner (nnp) at 1730.When hooking up uac fluids noticed that line was leaking just below the hub where fluids are connected.Nnp notified and line was replaced.

• Type of Device: CATHETER, UMBILICAL ARTERY
• MDR Report Key: 10875842
• MDR Text Key: 217445635
• Report Number: 10875842
• 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
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1924700105
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 DA