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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UTAH MEDICAL PRODUCTS INC. UMBILI-CATH 3.5 DUAL-LUMEN POLYURETHANE CATHETER UVC / CATHETER, UMBILICAL ARTERY

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UTAH MEDICAL PRODUCTS INC. UMBILI-CATH 3.5 DUAL-LUMEN POLYURETHANE CATHETER UVC / CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 4283505
Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/30/2018
Event Type  Injury  
Event Description
Umbilical venus catheter noted to be leaking at 0700am from a small hole between 9cm and 10cm mark on catheter. Uv was dc'd and peripheral ivs placed. Est iv fluid loss 1-2ml. No complications noted, however md ordered picc placement. Diagnosis or reason for use: newborn.
 
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Brand NameUMBILI-CATH 3.5 DUAL-LUMEN POLYURETHANE CATHETER
Type of DeviceUVC / CATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
UTAH MEDICAL PRODUCTS INC.
7043 south 300 west
midvale UT 84047
MDR Report Key7880617
MDR Text Key120556454
Report NumberMW5079826
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2018
Device Model Number4283505
Device Catalogue NumberP/N 50824
Device Lot Number1141816
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/14/2018 Patient Sequence Number: 1
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