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

Model Number DUAL-LUMEN SILICONE

Device Problem Break (1069)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 10/29/2021

Event Type  malfunction  

Event Description

The new footprint's dual lumen 3.5fr umbilical venous catheter broke under no specific causation where the two lumens come together at line.The patient was an extremely premature infant on tpn (total parenteral nutrition) and two pressors (dopamine and norepi).The bedside rn and practitioner were present when it occurred.A 26ga piv (peripheral intravenous) was emergently placed in the left arm and the fluids were transferred to the piv until pharmacy could re-mix concentrations for piv.The remainder of the uvc (umbilical venous catheter) line was pulled, and pressure held.Pvat was also immediately notified for an urgent picc (peripherally inserted central catheter) and mother was updated by phone.The patient experienced brief hypotension and the need for an early picc.

• 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: 12786422
• MDR Text Key: 280593353
• Report Number: 12786422
• 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: 11/02/2021

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 Model Number: DUAL-LUMEN SILICONE
• Device Catalogue Number: 4273505
• Device Lot Number: 1211428
• 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: 11/02/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 3 DA
• Patient Sex: Male
• Patient Race: Black Or African American