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U.S. Department of Health and Human Services

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

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UTAH MEDICAL PRODUCTS, INC. UMBILI-CATH DUAL-LUMEN UMBILICAL CATHETER CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 4273505
Device Problems Fracture (1260); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/30/2020
Event Type  Injury  
Event Description
Nurse lifted uvc tubing to adjust and wrap infant. Noted uvc in 2 pieces. Uvc had fractured at area of bifurcation. A knot was tied in line by rn to prevent bleeding. No significant bleeding from uvc line. No patient harm. No indication that line had fractured prior to nurse discovering. It was reported that pump had alarmed "occlusion" several times prior to discovery. Fda safety report id# (b)(4).
 
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Brand NameUMBILI-CATH DUAL-LUMEN UMBILICAL CATHETER
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
UTAH MEDICAL PRODUCTS, INC.
midvale UT 84047
MDR Report Key11125205
MDR Text Key225508484
Report NumberMW5098676
Device Sequence Number1
Product Code FOS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number4273505
Device Lot Number1200619
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/05/2021 Patient Sequence Number: 1
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