Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORTRAK 2 ENTERAL ACCESS SYSTEM; DH CORTRAK (EAS)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AVANOS MEDICAL INC. CORTRAK 2 ENTERAL ACCESS SYSTEM; DH CORTRAK (EAS) Back to Search Results
Model Number 20-0950
Device Problem Malposition of Device (2616)
Patient Problems Death (1802); Pneumothorax (2012)
Event Type  Death  
Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 02 jan 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).
 
Event Description
Avanos medical inc.Received a single report that referenced 12 different incidences, which were associated with separate units, involving 12 different patients.This is the sixth of twelve reports.Refer to 3011270181-2020-00001 for the first report.Refer to 3011270181-2020-00002 for the second report.Refer to 3011270181-2020-00003 for the third report.Refer to 3011270181-2020-00004 for the fourth report.Refer to 3011270181-2020-00005 for the fifth report.Refer to 3011270181-2020-00007 for the seventh report.Refer to 3011270181-2020-00008 for the eighth report.Refer to 3011270181-2020-00009 for the ninth report.Refer to 3011270181-2020-00010 for the tenth report.Refer to 3011270181-2020-00011 for the eleventh report.Refer to 3011270181-2020-00012 for the twelfth report.It was reported in "undetected cortrak tube misplacements in the (b)(6), (b)(6) 2010: an audit of trace interpretation" (b)(6) that sometime between 2010 and 2017, a nasogastric tube was placed in the patient's lung.Placement was not confirmed by x-ray, and the patient received feed.The patient died.No further information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CORTRAK 2 ENTERAL ACCESS SYSTEM
Type of Device
DH CORTRAK (EAS)
Manufacturer (Section D)
AVANOS MEDICAL INC.
5405 windward parkway
alpharetta GA 30004
Manufacturer (Section G)
CORPAK MEDSYSTEMS INC A DIVISION OF AVANOS
1001 asbury dr
buffalo grove IL 60089
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key9552890
MDR Text Key173761098
Report Number3011270181-2020-00006
Device Sequence Number1
Product Code KNT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K113351
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2020
Device Operator Health Professional
Device Model Number20-0950
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-