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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL ARROWGARD BLUE MAC TWO LUMEN CENTRAL VENOUS ACCESS CATHETER

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ARROW INTERNATIONAL ARROWGARD BLUE MAC TWO LUMEN CENTRAL VENOUS ACCESS CATHETER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hemorrhage/Bleeding (1888)
Event Date 09/10/2019
Event Type  Death  
Event Description
The pa catheter was discontinued from the two lumen central venous access catheter. Two hours later, the pt coded and bleeding was noted existing the introducer.
 
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Brand NameARROWGARD BLUE MAC
Type of DeviceTWO LUMEN CENTRAL VENOUS ACCESS CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL
reading PA
MDR Report Key9329411
MDR Text Key166767728
Report Number9329411
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/19/2019
Distributor Facility Aware Date09/10/2019
Event Location Hospital
Date Report to Manufacturer09/19/2019
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 11/14/2019 Patient Sequence Number: 1
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