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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION THORA-PARA TRAY; GENERAL SURGERY TRAY
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CAREFUSION THORA-PARA TRAY; GENERAL SURGERY TRAY Back to Search Results
Lot Number 0001044919
Device Problem Material Integrity Problem (2978)
Patient Problem Needle Stick/Puncture (2462)
Event Date 06/05/2017
Event Type  malfunction  
Event Description
Pulmonary fellow, performed a thoracentesis on patient.Following the procedure, the fellow was cleaning up.The thoracentesis tray is plastic.There is a location on the tray for a sponge to be placed.The soiled needles are stuck in the sponge on the plastic tray.The soiled needle was placed in the sponge but the needle when through the foam needle stop and through the bottom of the tray.When the fellow picked up the tray to dispose, she was stuck by the needle that went through the bottom of the tray.
 
Manufacturer Narrative
The following elements have blank data.
 
Event Description
Pulmonary fellow, performed a thoracentesis on patient.Following the procedure, the fellow was cleaning up.The thoracentesis tray is plastic.There is a location on the tray for a sponge to be placed.The soiled needles are stuck in the sponge on the plastic tray.The soiled needle was placed in the sponge but the needle when through the foam needle stop and through the bottom of the tray.When the fellow picked up the tray to dispose, she was stuck by the needle that went through the bottom of the tray.
 
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Brand Name
THORA-PARA TRAY
Type of Device
GENERAL SURGERY TRAY
Manufacturer (Section D)
CAREFUSION
75 north fairway dr.
vernon hills IL 60061
MDR Report Key6663007
MDR Text Key78280228
Report Number6663007
Device Sequence Number1
Product Code LRO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2017
Is this a Product Problem Report? Yes
Device Operator No Information
Device Lot Number0001044919
Other Device ID NumberTHORA-PARA 8FR CATHETER DRAIN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/07/2017
Event Location Hospital
Date Report to Manufacturer06/07/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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