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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2020

Event Type  malfunction  

Event Description

Nurse was performing a routine assessment.When rn went to move umbilical vessel catheter (uvc) line out from underneath patient, the line "snapped" and disconnected from the rest of the line setup.The uvc was pulled per the provider and was inspected and verified by rn twice that catheter was otherwise 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: 11193442
• MDR Text Key: 227525589
• Report Number: 11193442
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1