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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 4273505
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/23/2017
Event Type  malfunction  
Event Description
Male infant delivered at 26wk/1day via vaginal delivery w/ apgar's 2/6. Umbilical venous catheter (uvc) and umbilical arterial catheter (uac) both placed after delivery. Uvc was a 3. 5 fr double lumen. It was secured with suture but cm marking is not provided to this reporter and not available in patient's emr. Lateral x-ray showed the uvc to be high. The uvc was then retracted by 0. 5 cm per md order. Uac removed. During care, the rn assessed the umbilicus area to be wet. The nnp was called to the bedside. It was determined that the catheter was leaking. The uvc had remained in position from the previous repositioning on day 2. According to the care rn, staff were unable to determine where the uvc was leaking. Tubing to the uvc had been changed 1 hr earlier and no leaking was noted at that time. No clamps were in use that could have contributed to leaking. The rn reported the uvc remained sutured but did not appear excessively tight. The uvc was removed per nnp order.
 
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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 1048
MDR Report Key7181717
MDR Text Key96973103
Report Number7181717
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 12/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4273505
Device Lot Number11663555
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/29/2017
Event Location Hospital
Date Report to Manufacturer12/29/2017
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: 01/11/2018 Patient Sequence Number: 1
Treatment
THE PATIENT HAD A UAC IN PLACE UP UNTIL 1 DAY PRIO
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