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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 DUAL-LUMEN SILICONE
Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2018
Event Type  malfunction  
Event Description
Umbilical catheter was used for blood draw on neonate. Nurse went to return blood and somewhere near the catheter junction, the line busted/squirted out/burst open. Manufacturer response for 3. 5 french dual lumen silicone uvc catheter, utah medical (per site reporter).
 
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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 Key7983979
MDR Text Key124344747
Report Number7983979
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 Other Health Care Professional
Type of Report Initial
Report Date 10/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDUAL-LUMEN SILICONE
Device Catalogue Number4273505
Device Lot Number1151487
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/12/2018
Event Location Hospital
Date Report to Manufacturer10/19/2018
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

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