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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UTAH MEDICAL PRODUCTS, INC. UMBILI-CATH; UMBILICAL CATHATER
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UTAH MEDICAL PRODUCTS, INC. UMBILI-CATH; UMBILICAL CATHATER Back to Search Results
Catalog Number 4273505
Device Problem Use of Device Problem (1670)
Patient Problem Perforation of Vessels (2135)
Event Date 11/03/2019
Event Type  malfunction  
Manufacturer Narrative
Utmd is reporting this event because the user reported that the vena cava was perforated during the use of the device.As stated in the report to utmd from the hospital, this can be a complication.
 
Event Description
The patient received increasing fluid in the abdomen.The patient was transferred to the ous.The ous examination stated that it appeared that the there was a perforation of the vena cava caused by the, (placement of the) umbilical catheter.
 
Event Description
The patient received increasing fluid in the abdomen.The patient was transferred to the ous.The ous examination stated that it "appeared" that the there was a perforation of the vena cava caused by the, (placement of the) umbilical catheter.
 
Manufacturer Narrative
Utmd is reporting this event because the user reported that the vena cava was perforated during the use of the device.As stated in the report to utmd from the hospital, this can be a complication.
 
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Brand Name
UMBILI-CATH
Type of Device
UMBILICAL CATHATER
Manufacturer (Section D)
UTAH MEDICAL PRODUCTS, INC.
7043 south 300 west
midvale UT 84047
MDR Report Key9490340
MDR Text Key191197200
Report Number1718873-2019-00003
Device Sequence Number1
Product Code FOS
Combination Product (y/n)N
PMA/PMN Number
K940952
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 11/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/11/2024
Device Catalogue Number4273505
Device Lot Number1182791
Was Device Available for Evaluation? No
Device Age1 WK
Event Location Hospital
Date Report to Manufacturer11/20/2019
Date Manufacturer Received11/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age1 DA
Patient Weight2
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