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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CATHETER, UMBILICAL ARTERY

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CATHETER, UMBILICAL ARTERY Back to Search Results
Lot Number 1924700105
Device Problem Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 06/03/2020
Event Type  malfunction  
Event Description
Uac inserted by neonatal nurse practitioner (nnp) at 1730. When hooking up uac fluids noticed that line was leaking just below the hub where fluids are connected. Nnp notified and line was replaced.
 
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Type of DeviceCATHETER, UMBILICAL ARTERY
MDR Report Key10875842
MDR Text Key217445635
Report Number10875842
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 10/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number1924700105
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/09/2020
Event Location Hospital
Date Report to Manufacturer11/19/2020
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?
Type of Device Usage Unkown

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