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U.S. Department of Health and Human Services

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

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UTAH MEDICAL PRODUCTS UMBILI-CATH CATHETER, UMBILICAL ARTERY Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem Fluid Discharge (2686)
Event Date 01/11/2018
Event Type  malfunction  
Manufacturer Narrative
The following elements have blank data.
 
Event Description
Rn assessed patient 21:00. No leaking noted from uac when started assessment. Turned patient from left side to supine position. At 21:05, noted leaking of very small amount of blood from uac catheter where actual catheter meets the hub. Uac clamped and advanced practitioner immediately contacted and came to bedside. Uac line examined and leaking from actual uac confirmed. Uac removed and intra lipids-nutrition (il) infusion discontinued. Feeds advanced, and rn instructed to recheck blood sugar level at 23:00, to determine if patient needs peripheral intravenous (piv) placed for additional intravenous fluids (ivfs).
 
Event Description
Rn assessed patient 21:00. No leaking noted from (b)(6) when started assessment. Turned patient from left side to supine position. At 21:05, noted leaking of very small amount of blood from (b)(6) catheter where actual catheter meets the hub. (b)(6) clamped and advanced practitioner immediately contacted and came to bedside. (b)(6) line examined and leaking from actual (b)(6) confirmed. (b)(6) removed and il infusion discontinued. Feeds advanced, and rn instructed to recheck blood sugar level at 23:00, to determine if patient needs piv placed for additional ivfs.
 
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Brand NameUMBILI-CATH
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
UTAH MEDICAL PRODUCTS
7043 south 300 west
midvale UT 84047
MDR Report Key7224259
MDR Text Key273194451
Report Number7224259
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,Followup
Report Date 01/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Other Device ID NumberSINGLE-LUMEN POLYURETHANE UMB
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/15/2018
Event Location Hospital
Date Report to Manufacturer01/15/2018
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: 01/29/2018 Patient Sequence Number: 1
Treatment
NOT KNOWN.
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