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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
Model Number 5-FR.
Device Problems Break (1069); Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/14/2016
Event Type  malfunction  
Event Description
The infant had a umbilical line placed by the physician at bedside. On x-ray, the line was shown to be placed too deeply and was attempted to be pulled back by physician. During attempt to pull back, the umbilical line snapped at the suture line. The 5 fr. Utah medical umbilical line catheter snapped at suture line during line readjustment. Line lot #1161148 from utah medical supplies ((b)(4)). Due to the critical condition of infant, surgeons were called to the bedside to retrieve the catheter. An incision was made at the cord and the line was successfully retrieved. The infant was supported during process and was left in stable condition.
 
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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 Key6431663
MDR Text Key70788353
Report Number6431663
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number5-FR.
Device Lot Number1161148
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/08/2017
Event Location Hospital
Date Report to Manufacturer03/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/24/2017 Patient Sequence Number: 1
Treatment
CARDIAC DRUGS; NO
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