• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC.PERCUTANEOUS ENTRY NEEDLEDWO NEEDLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 

COOK, INC. PERCUTANEOUS ENTRY NEEDLE DWO NEEDLE   Back to Search Results
Catalog Number SDN-18-7.0
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Malfunction  
Event Description

The physician noticed air leaking into the hub of the needle during venous sticks with a fluid-filled syringe.

 
Manufacturer Narrative

Unknown as lot is unknown. Evaluation: still under investigation.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERCUTANEOUS ENTRY NEEDLE
Type of DeviceDWO NEEDLE
Manufacturer (Section F)
COOK, INC.
750 daniels way
bloomington IN 47404
Manufacturer (Section D)
COOK, INC.
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
Manufacturer Contact
rita harden
750 daniels way
bloomington , IN 47404
(812) 339 -2235
Device Event Key975322
MDR Report Key972124
Event Key932769
Report Number1820334-2008-00001
Device Sequence Number1
Product CodeDWO
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/03/2007
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/02/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberSDN-18-7.0
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age na
Event Location Hospital
Was The Report Sent To Manufacturer? No
Date Manufacturer Received12/03/2007
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

-
-