Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C. R. BARD, INC. BARD M11209; PORT CATHETER IMPLANTED SUBCUTANEOUS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

C. R. BARD, INC. BARD M11209; PORT CATHETER IMPLANTED SUBCUTANEOUS Back to Search Results
Device Problem Material Separation (1562)
Patient Problem Pericardial Effusion (3271)
Event Date 01/14/2020
Event Type  Injury  
Event Description
Chemo port and catheter placed at an outside facility in 2012 showed complete detachment of the catheter from the hub and the entire catheter within the right heart.This was revealed through a control film and echocardiogram transesophageal diagnostic tests.Pt started on xarelto.On (b)(6) 2020 port and catheter were extracted without complications and pt discharged home the same day in stable condition.A catheter is visualized in the right atrium.There is a suspicious mobile density attached to the catheter which may represent a portion of the catheter itself vs thrombus.Additionally, there is a small density attached to the lateral wall of the left atrium concerning for thrombus.There is a catheter also visualized in the right ventricle.The tip appears to be free within the ventricular apex.Small pericardial effusion.Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BARD M11209
Type of Device
PORT CATHETER IMPLANTED SUBCUTANEOUS
Manufacturer (Section D)
C. R. BARD, INC.
MDR Report Key9711438
MDR Text Key179785449
Report NumberMW5093003
Device Sequence Number1
Product Code LJT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age65 YR
Patient Weight58
-
-