FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

C.R. BARD BARD ACCESS SYSTEMS BARD PORT WITH GROSHONG CATHETER   back to search results
Model Number 0602850
Device Problems Fracture(s) of device/material; Implant, removal of
Event Date 02/16/2004
Patient Outcome  Required Intervention;
Event Description

Pt was taken to radiology special preocedures suite for removal of a fractured mediport catheter with the distal end emolized to the heart. Access was obtained in the right common femoral vein with ultrasound guidance. A 25mm looped snare was used & successfully engaged to the fractured catheter piece to remove it from the right atrium & ventricle.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameBARD ACCESS SYSTEMS
Type of DeviceBARD PORT WITH GROSHONG CATHETER
Baseline Brand NameTITANIUM DOME PORT W/ATT GROSHONG 8.0 FR CATH
Baseline Generic NameINTRAVASCULAR IMPLANTED PORTS
Baseline Catalogue Number0602850
Baseline Model Number0602850
Baseline Device FamilyTITANIUM PORTS
Baseline Device 510(K) NumberK870260
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed04/15/1987
Manufacturer (Section F)
C.R. BARD
salt lake city UT *
Manufacturer (Section D)
C.R. BARD
salt lake city UT *
Device Event Key507163
MDR Report Key518127
Event Key491662
Report Number518127
Device Sequence Number1
Product CodeLJT
Report Source User Facility
Reporter Occupation Invalid Data
Type of Report Initial
Report Date 03/18/2004
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/24/2004
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number0602850
Device Catalogue Number0602850
Device LOT Number22AM8056
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/20/2004
Device Age1.5 yr
Event Location Hospital
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on January 30, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH