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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 Component Missing (2306)
Patient Problem Insufficient Information (4580)
Event Date 05/28/2021
Event Type  malfunction  
Event Description
Rn opened uvc tray for placement in premature infant. Iodine swabstick is to be supplied in the kit and this kit was missing the iodine swabstick. Swabstick was able to be obtained from supply room.
 
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Brand NameARGYLE
Type of DeviceCATHETER, UMBILICAL ARTERY
Manufacturer (Section D)
CARDINAL HEALTH, INC.
15 hampshire street
mansfield MA 02048
MDR Report Key12007906
MDR Text Key256463087
Report Number12007906
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 06/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8888160424
Device Catalogue Number8888160424
Device Lot Number2023700129
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/10/2021
Event Location Hospital
Date Report to Manufacturer06/16/2021
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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