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

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.

• Brand Name: HICKMAN CENTRAL VENOUS CATHETER
• Type of Device: CATHETERS, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): C. R. BARD
• MDR Report Key: 7850516
• MDR Text Key: 119650134
• Report Number: MW5079594
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 09/05/2018
• 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