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

Model Number SINGLE-LUMEN SILICONE

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/19/2021

Event Type  malfunction  

Event Description

While nurse was carrying out order to pull back umbilical artery catheter, catheter snapped in half.Nurse very quickly grabbed line and notified physician.Physician was able to take the rest of the line out.Infant did lose about 5 ml of blood during the procedure.Umbili-cath-single lumen silicone umbilical catheter 3.5 french; lot # 1202974.

• 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: 12142245
• MDR Text Key: 260708817
• Report Number: 12142245
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SINGLE-LUMEN SILICONE
• Device Catalogue Number: 4173505
• Device Lot Number: 1202974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1