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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORPAK MEDSYSTEMS, INC. CORTRAK 2 EAS; FEEDING TUBE
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CORPAK MEDSYSTEMS, INC. CORTRAK 2 EAS; FEEDING TUBE Back to Search Results
Model Number 20-9431 TRAK 2
Device Problems Difficult to Advance (2920); Positioning Problem (3009)
Patient Problem Pneumothorax (2012)
Event Date 02/22/2014
Event Type  Injury  
Event Description
Stroke pt, who was unable to follow a command to swallow, needed a feeding tube placed.The first attempt by the nurses to place a cortrak ended when resistance was met at 50 cm.Tube was withdrawn.A second attempt met no resistance and was advanced to 60 cm and secured.No auscultation was noted when 30 cc air was pushed.On the screen, the tube did not appear to be in the abdomen.The tube was withdrawn and minutes later, the pt started to wheeze.Cxr revealed at right moderate pneumothorax.A chest tube was inserted and removed two days later.Cortrak 2 eas was used with both attempts.
 
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Brand Name
CORTRAK 2 EAS
Type of Device
FEEDING TUBE
Manufacturer (Section D)
CORPAK MEDSYSTEMS, INC.
buffalo grove IL 60089
MDR Report Key3750350
MDR Text Key4421758
Report Number3750350
Device Sequence Number1
Product Code KNT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/05/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number20-9431 TRAK 2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/05/2014
Distributor Facility Aware Date02/22/2014
Event Location Hospital
Date Report to Manufacturer03/05/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/06/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age90 YR
Patient Weight57
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