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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 8888160424
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 12/07/2020
Event Type  malfunction  
Event Description
A piece of the hemostat which comes in the umbilical venous catheter (uvc) packaging broke off when physician was attempting to insert line.
 
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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 Key11087021
MDR Text Key224107718
Report Number11087021
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
Type of Report Initial
Report Date 12/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160424
Device Catalogue Number8888160424
Device Lot Number2010400046
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/17/2020
Event Location Hospital
Date Report to Manufacturer12/29/2020
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? No
Type of Device Usage Unkown

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