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

Model Number DUAL-LUMEN SILICONE

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/28/2022

Event Type  malfunction  

Event Description

Neonatologist placed double lumen uvc and sutured in place.X-ray confirmation of placement revealed catheter needed to be withdrawn.Neonatologist attempted to gently pull on catheter to withdraw when the catheter broke.The neonatologist was able to grasp the remaining end of the catheter and remove from patient before entered circulation and without incident.Withdrawn catheter was intact.

• Brand Name: UMBILI-CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC.; 7043 south 300 west; midvale UT 84047
• MDR Report Key: 16194030
• MDR Text Key: 307574840
• Report Number: 16194030
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DUAL-LUMEN SILICONE
• Device Catalogue Number: 4275005
• Device Lot Number: 1223034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1