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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. WAYNE PNEUMOTHORAX TRAY CANNULA, CATHETER

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COOK, INC. WAYNE PNEUMOTHORAX TRAY CANNULA, CATHETER Back to Search Results
Catalog Number REF G56537
Device Problem Physical Resistance (2578)
Patient Problems Purulent Discharge (1812); Staphylococcus Aureus (2058); Septic Shock (2068)
Event Date 12/23/2015
Event Type  Injury  
Event Description
Pt admitted with septic shock 2/2 staph aureus, and left sided empyema. After diagnostic thoracentesis revealed empyema, a left chest tube was inserted. Needle entered pleural space normally. The wire fed easily, skin and subcutaneous tissues dilated normally. Chest tube was introduced, however when attempting to remove wire and last dilator out of chest tube, there was significant resistance. The dilator was able to be removed easily, however the wire remained resistant. With some manipulation, the wire was removed, however noted to have some portion of the wire remaining within chest tube/pleural space. It was confirmed to be exiting the distal portion of the chest tube on the post-placement cxr. Vir recommended no intervention at this time and when time for chest removal, do it under fluoroscopy. The patient's chest tube was removed and the wire came out with the tube.
 
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Brand NameWAYNE PNEUMOTHORAX TRAY
Type of DeviceCANNULA, CATHETER
Manufacturer (Section D)
COOK, INC.
750 daniels way
bloomington IN 47404
MDR Report Key5466025
MDR Text Key39208069
Report Number5466025
Device Sequence Number1
Product Code DQR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/20/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/29/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberREF G56537
Other Device ID NumberSIZE: 14.0FR/29CM
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/20/2016
Event Location Hospital
Date Report to Manufacturer01/20/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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