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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 3.5
Device Problems Break (1069); Entrapment of Device (1212); Leak/Splash (1354); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/07/2016
Event Type  malfunction  
Event Description
I was called to the bedside as the charge rn to look at a uac that was leaking from the umbilicus.After flushing the line again and witnessing the leaking, i called the dr to troubleshoot the uac.After flushing the line, he tried to gently pull the line out a little bit and it snapped in half.We immediately tried to retrieve the broken catheter with hemostats but he was unable to grasp it and pulled back into the vessel where it was unable to be visualized.We notified the dr of the broken catheter and he ordered an x-ray to view the location of the catheter and came to the bedside.He did an emergency cutdown of the umbilicus and removal of the catheter.He was able to remove the 11cm of catheter from the baby intact.The baby remained stable throughout the next shift.There were no complications.Umbilical incision intact without redness or drainage.Umbilical catheter 3.5 lot # 1152069.
 
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Brand Name
UMBILI-CATH
Type of Device
CATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
UTAH MEDICAL PRODUCTS, INC.
7043 south 300 west
midvale, UT 84047
MDR Report Key5758158
MDR Text Key48436582
Report Number5758158
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 Other
Type of Report Initial
Report Date 05/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Unknown
Device Model Number3.5
Device Lot Number1152069
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/24/2016
Event Location Hospital
Date Report to Manufacturer05/24/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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