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

DEROYAL CRITICAL CARE DEROYAL/UNKNOWN 20 GA X 2" IV CATHETER   back to search results
Event Date 05/25/1997
Patient Outcome  Required Intervention;
Event Description

On 5/24/97 arterial wave form noted to be flat. On inspection of catheter site the nurse described the catheter as "kinked". On attempt to unkink the suture was clipped and the catheter dislodged. On examination of the catheter it was noted to be sheared. At an angle.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameDEROYAL/UNKNOWN
Type of Device20 GA X 2" IV CATHETER
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
DEROYAL CRITICAL CARE
200 debusic lane
powell TN 37849
Manufacturer (Section D)
DEROYAL CRITICAL CARE
200 debusic lane
powell TN 37849
Device Event Key104859
MDR Report Key106676
Event Key100273
Report Number106676
Device Sequence Number1
Product CodeDQO
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 06/20/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/18/1997
Is This An Adverse Event Report? Yes
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 the Report Sent to FDA? No
Distributor Facility Aware Date05/27/1997
Event Location Hospital
Date Report TO Manufacturer06/20/1997
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 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