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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED PNEUMOTHORAX SET CANNULA, CATHETER

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COOK INCORPORATED PNEUMOTHORAX SET CANNULA, CATHETER Back to Search Results
Model Number C-TPT-200
Device Problems Difficult to Remove (1528); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
While edp using the cook brand pneumo dart with lot #3139854 expiry, 06/27/2018, he was not able to thread catheter off the guide needle. He stopped procedure and actually had to use quite a bit of strength and a hemostat to remove from needle. Patient then was sent to ct for insertion of chest tube.
 
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Brand NamePNEUMOTHORAX SET
Type of DeviceCANNULA, CATHETER
Manufacturer (Section D)
COOK INCORPORATED
po box 489
bloomington IN 47402 0489
MDR Report Key6453135
MDR Text Key71697404
Report NumberMW5068845
Device Sequence Number1
Product Code DQR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Caregivers
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/27/2018
Device Model NumberC-TPT-200
Device Catalogue NumberG03302
Device Lot Number7139854
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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