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

Model Number SINGLE-LUMEN POLYURETHANE

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 06/21/2021

Event Type  malfunction  

Event Description

Uvc cracked.

• 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: 12091789
• MDR Text Key: 259175050
• Report Number: 12091789
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SINGLE-LUMEN POLYURETHANE
• Device Catalogue Number: 4182805
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1