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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE CATHETER, UMBILICAL ARTERY

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CARDINAL HEALTH, INC. ARGYLE CATHETER, UMBILICAL ARTERY Back to Search Results
Model Number 8888160648
Device Problem Crack (1135)
Patient Problem Insufficient Information (4580)
Event Date 03/31/2021
Event Type  malfunction  
Event Description
A cardiac patient had a triple lumen umbilical vessel catheter and after placement, multiple fluid boluses and drips were ordered. The providers requested the bedside nurse hand push boluses instead of running them on a pump. The nurses had a hard time hand pushing the meds because there was a lot of resistance. It was discovered that there was a crack in the tertiary lumen after the echo tech felt the fluid from the boluses splashing him. Neonatal nurse practitioner was notified and replaced the triple lumen umbilical vessel catheter with another.
 
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Brand NameARGYLE
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
CARDINAL HEALTH, INC.
3651 birchwood drive
waukegan IL 60085
MDR Report Key11692843
MDR Text Key246277016
Report Number11692843
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 Risk Manager
Type of Report Initial
Report Date 04/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160648
Device Catalogue Number8888160648
Device Lot Number1921900151
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/05/2021
Event Location Hospital
Date Report to Manufacturer04/20/2021
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 Unkown

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