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 ACCESS SYSTEMS BARD ACCESS SYSTEMS IMPLANTED BLOOD ACCESS DEVICE   back to search results
Device Problems Crack(s); Implant, removal of
Event Date 09/11/2000
Event Type  Malfunction   Patient Outcome  Required Intervention;
Event Description

Connector break, no additional info was provided.

 
Manufacturer Narrative

A complaint history review is not possible because no lot number was provided. The complaint is inconclusive per no product was returned for evaluation.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameBARD ACCESS SYSTEMS
Type of DeviceIMPLANTED BLOOD ACCESS DEVICE
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BARD ACCESS SYSTEMS
5425 west amelia earhart dr.
salt lake city UT 84116
Manufacturer (Section D)
BARD ACCESS SYSTEMS
5425 west amelia earhart dr.
salt lake city UT 84116
Manufacturer Contact
bryan ball, mgr.
5425 west amelia earhart dr.
salt lake city , UT 84116
(801) 595 -0700
Device Event Key299931
MDR Report Key310018
Event Key291388
Report Number1720496-2000-00662
Device Sequence Number1
Product CodeDQO
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 11/20/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/11/2000
Device Ageno info
Event Location Hospital
Date Report TO Manufacturer11/20/2000
Date Manufacturer Received11/20/2000
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

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