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

Device Problem Break (1069)

Patient Problem Missed Dose (2561)

Event Date 06/26/2019

Event Type  malfunction  

Event Description

At time of line change while attempting to disconnect the umbilical arterial catheter, it broke at the site of connection to the lines.Rendering the umbilical arterial catheter un-usable.Umbilical arterial catheter had to be removed, and patient not able to receive total parenteral nutrition.

• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC.; 7043 south 300 west; medvale UT 84047
• MDR Report Key: 9081919
• MDR Text Key: 159017651
• Report Number: 9081919
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2019
• Type of Device Usage: N
• Patient Sequence Number: 1