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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UTAH MEDICAL PRODUCTS INC. UMBILI-CATH; UMBILICAL VESSEL CATHETER

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UTAH MEDICAL PRODUCTS INC. UMBILI-CATH; UMBILICAL VESSEL CATHETER Back to Search Results
Catalog Number 131167
Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/28/2018
Event Type  malfunction  
Event Description
Transport nurse clamped the umbilical vessel catheter (uvc) to switch the fluids for transport with a 2x2 and clamp and when she released the clamp the catheter was pierced and leaking blood.The uvc was re-clamped and removed due to leaking catheter.
 
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Brand Name
UMBILI-CATH
Type of Device
UMBILICAL VESSEL CATHETER
Manufacturer (Section D)
UTAH MEDICAL PRODUCTS INC.
7043 south 300 west
midvale UT 84047
MDR Report Key7530712
MDR Text Key108806001
Report Number7530712
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 02/06/2018,04/13/2018
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 No Information
Device Expiration Date05/15/2022
Device Catalogue Number131167
Device Lot Number1716600018
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/06/2018
Event Location Hospital
Date Report to Manufacturer02/06/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/21/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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