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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORPAK / AVANOS MEDICAL INC. CORTRAK; TUBE, FEEDING
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CORPAK / AVANOS MEDICAL INC. CORTRAK; TUBE, FEEDING Back to Search Results
Device Problem Positioning Problem (3009)
Patient Problem Pneumothorax (2012)
Event Date 08/10/2019
Event Type  Injury  
Event Description
Post pyloric feeding tube placed with cortrak device into left lung.Md notified, cxr 3 days later showed 25-30% pneumothorax which required chest tube to resolve; 1308 feeding tube could be within distal esophagus or lung, feeding tube withdrawal and replacement is recommended; 1516 kub keofeed probably in proximal stomach; 1558 cxr feeding tube appears to extend into left mainstem bronchus and appears to be in the left hemithorax possibly in pleural space; however, no left pleural effusion or pneumothorax is seen.F/u cxr within one hour is suggested.On 08/13, 0400 left side pneumothorax approximated at least 25- 30%; 1647 interval decrease in size of left pneumothorax following placement of small bore left chest tube.On 08/14 1323 near complete full expansion with less than 5% pneumo.On 08/15 1624 no identifiable pneumothorax is present.Fda safety report id# (b)(4).
 
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Brand Name
CORTRAK
Type of Device
TUBE, FEEDING
Manufacturer (Section D)
CORPAK / AVANOS MEDICAL INC.
MDR Report Key9028055
MDR Text Key158652321
Report NumberMW5089760
Device Sequence Number1
Product Code FPD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
Patient Weight113
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