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

BARD MEDIPORT VENOUS ACCESS DEVICE   back to search results
Model Number 4401851 T1
Event Date 01/25/1995
Patient Outcome  Required Intervention;
Event Description

On 1/25/95, pt admitted with emboli infusion port catheter which had embolized from right subclavian through right side of heart to the left lower lobe. Pt had severe pleuritic chest pains & hemoptysis. Retrieval of catheter done percutaneously. Lung scan showed evidence of p. E. Pt was heparinized prior to d/c. Readmitted 4/12/95 to remove remaining portion of device.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameMEDIPORT
Type of DeviceVENOUS ACCESS DEVICE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BARD
4317 noyrey drive
metairie LA 70002
Manufacturer (Section D)
BARD
4317 noyrey drive
metairie LA 70002
Device Event Key24793
MDR Report Key24436
Event Key22683
Report Number24436
Device Sequence Number1
Product CodeLJT
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/20/1995,04/12/1995
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/1995
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number4401851 T1
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/12/1995
Device Age6 mo
Event Location Home
Date Report TO Manufacturer04/20/1995
Is the Device an Implant? Yes
Is this an Explanted Device?

Database last updated on January 06, 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