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U.S. Department of Health and Human Services

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

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UTAH MEDICAL PRODUCTS, INC. UMBILI-CATH CATHETER, UMBILICAL ARTERY Back to Search Results
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.
 
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Brand NameUMBILI-CATH
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
UTAH MEDICAL PRODUCTS, INC.
7043 south 300 west
midvale UT 84047
MDR Report Key11193442
MDR Text Key227525589
Report Number11193442
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received01/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/22/2020
Event Location Hospital
Date Report to Manufacturer01/19/2021
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 Unkown

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