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

Model Number SINGLE-LUMEN SILICONE

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2019

Event Type  malfunction  

Event Description

It was used as an umbilical arterial catheter and was sutured at 14 cm.The line was clamped to change iv fluids and it snapped just after the hub.There was no patient harm as the catheter was clamped.It was placed, and this occurred 3 days later.Clamped uac using 2x2 folded over line and hemostats clamped.After scrubbing the line, attempting to twist off the old iv tubing to replace with new when it just popped apart at the end of the catheter where it is attached to the hub.

• 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: 8599363
• MDR Text Key: 144703583
• Report Number: 8599363
• 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: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SINGLE-LUMEN SILICONE
• Device Catalogue Number: 4173505
• Device Lot Number: 1181222
• 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: 04/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3 DA