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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C. R. BARD HICKMAN CENTRAL VENOUS CATHETER CATHETERS, INTRAVASCULAR, THERAPEUTIC

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C. R. BARD HICKMAN CENTRAL VENOUS CATHETER CATHETERS, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Hematoma (1884); Blood Loss (2597)
Event Date 08/23/2018
Event Type  Injury  
Event Description
The pt hickman catheter caused significant blood loss through the access site around the catheter. Blood was aggressively draining until pt called for help and pressure was applied. Hematoma was noted around hickman after bleeding controlled.
 
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Brand NameHICKMAN CENTRAL VENOUS CATHETER
Type of DeviceCATHETERS, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
C. R. BARD
MDR Report Key7850516
MDR Text Key119650134
Report NumberMW5079594
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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: 09/05/2018 Patient Sequence Number: 1
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