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

BD BD INSYTE AUTOGUARD IV CATHETER   back to search results
Catalog Number REF # 381423
Patient Outcome  Required Intervention;
Event Description

Pt. Having a ct scan with contrast, 300 omnipaque, 22 gauge bd insyte autoguard catheter used, checked with saline and determined to be patent before the test. Test injected with power injector and then injection began. 129 cc's of 150cc's infused when injector stopped. Pt noted to have contrast splattered on them. Catheter had ruptured, separating catheter from hub. Staff able to remove catheter from hub. Staff able to remove catheter from patient's right antecubital space without incidence of catheter migration. Note: they have had 2 previous events of this nature with this product. Manufacturer has been notified of 2 previous events and has worked to resolve the problem with product changes however new product not available to the hospital yet.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameBD INSYTE AUTOGUARD IV CATHETER
Type of DeviceIV CATHETER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
BD
1 becton drive
franklin lakes NJ 07417
Device Event Key429914
MDR Report Key440937
Event Key417367
Report NumberMW1027404
Device Sequence Number1
Product CodeFOZ
Report Source Voluntary
Report Date 01/30/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/30/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberREF # 381423
Device LOT Number111043
OTHER Device ID Number22 GA, 1.00 IN, 0.9 X 25MM
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

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