Halyard 47201Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10680651472011), received between Apr 3, 2018 and Jan 12, 2024 — classified as 4 deaths, 22 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Malposition of Device” (26 reports).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 21, 2022Terminated

   Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.

   Z-1032-2022 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2024Malposition of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED AN UNSPECIFIED INJURY OCCURRED WHEN THE CORTRAK 2 EAS WAS IN USE. THE USER NOTED A POTENTIAL CONTRIBUTING FACTOR OF THE PATIENT INJURY WAS THE PATIENT WAS "INTUBATED." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 18505946 ↗
• InjuryJul 26, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A PNEUMOTHORAX OCCURRED WHILE ATTEMPTING CORTRAK PLACEMENT. THE PATIENT WAS REPORTEDLY COMBATIVE DURING PLACEMENT AND HAD TO BE HELD DOWN. PER THE CLINICIAN, THERE WAS NO DROP IN OXYGEN THROUGHOUT PROCEDURE; HOWEVER, IT WAS NOTED THE NASOGASTRIC (NG) TUBE WAS COILED DURING INITIAL PLACEMENT WHICH WAS CONFIRMED BY THE INITIAL X-RAY AND THE TIP OF THE CATHETER WAS NOTED TO BE IN THE PATIENT¿S KNOWN LARGE HIATAL HERNIA. THE CLINICIAN REMOVED THE FEEDING TUBE AFTER THE ORIGINAL X-RAY. THE PATIENT REPORTEDLY SHOWED NO SIGNS OF DISTRESS AT THE TIME THAT THE FEEDING TUBE WAS REMOVED; HOWEVER, THE PATIENT'S MEDICAL STATUS DECLINED LATER ON IN THE DAY, AND THEY REQUIRED INTUBATION. A COMPUTERIZED TOMOGRAPHY (CT) OF THE CHEST WAS COMPLETED WHICH SHOWED A TENSION PNEUMOTHORAX AND THE ORIGINAL X-RAY WAS REREAD 2 DAYS LATER, ON (B)(6) 2022, AND WAS READ AS BEING IN THE RIGHT LUNG. THE PATIENT¿S CURRENT CONDITION WAS NOT REPORTED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2022 REPORTED, THE PATIENT WAS DOING WELL AND HAD BEEN TRANSFERRED TO THE FLOOR AND THEY WERE AWAITING A SWALLOW EVALUATION WITH SPEECH THERAPY.

  Patient problems: Pneumothorax

  MAUDE report 15105275 ↗
• InjuryMay 7, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A "RIGHT PLEURAL PNEUMOTHORAX" OCCURRED. IT WAS DISCOVERED BY "PINKISH ASPIRATE DURING INSERTION" AND THE RESOLUTION AND OUTCOME WAS "CHEST PIGTAIL, PATIENT STABLE." ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

  Patient problems: Pneumothorax

  MAUDE report 10036719 ↗
• InjuryMar 30, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THE CORTRAK DEVICE WAS USED FOR A NASOGASTRIC TUBE PLACEMENT ON (B)(6) 2020 AT 1130. THE PATIENT WAS ON A PULSE OXIMETER AND APPEARED STABLE. HE HAD A CONGESTED INTERMITTENT COUGH PRIOR TO THE PROCEDURE AND IT CONTINUED DURING THE PROCEDURE, WHICH WAS EXPECTED. THE PATIENT SWALLOWED AS HE WAS INSTRUCTED TO DO SO. THE PATIENT'S FULL COOPERATION WAS LIMITED BY CONFUSION. THE PATIENT'S OXYGEN SATURATIONS DROPPED TO 70% (ALSO EXPECTED) DURING THE PROCEDURE BUT RESOLVED WHEN THE CORTRAK TUBE WAS BRIDLED. AT 1230, THE RADIOLOGIST NOTED THE CORTRAK TUBE WAS MISPLACED IN THE LEFT PLEURAL SPACE VIA POTENTIAL LUNG PUNCTURE. THE PATIENT WAS STILL STABLE AND HIS PULSE OXIMETRY WAS CIRCA 90%. THE CORTRAK TUBE WAS REMOVED. THE PATIENT VERBALIZED AN IMPROVED ABILITY TO SPEAK. AT 1300 A FOLLOW-UP CHEST X-RAY SHOWED A PNEUMOTHORAX. AT 1800 THE PATIENT'S OXYGEN LEVEL DESATURATED TO 80% ON 5/LITERS OF OXYGEN VIA NASAL CANNULA. THE NURSE AND RESPIRATORY THERAPIST SWITCHED THE PATIENT TO 40% OXYGEN (8/LITERS) PER VENTI MASK. THE CHEST X-RAY WAS STABLE. ON (B)(6) 2020 AT 1314 THE CORTRAK IMPRESSION NOTED: MALPOSITIONED FEEDING TUBE EXTENDING INTO THE LEFT HEMITHORAX CONCERNING FOR LUNG P

  Patient problems: Hemothorax; Low Oxygen Saturation; Pleural Effusion; Pneumothorax

  MAUDE report 9896810 ↗
• DeathMar 18, 2020Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  IT WAS REPORTED A CLINICIAN NOT ON THE CORTRAK TEAM ATTEMPTED TO INSERT A NASO-INTESTINAL (NI) TUBE WITH THE CORTRAK DEVICE. THE TRACING SHOWED THE "TUBE OBVIOUSLY WAS GOING TOWARD THE RIGHT LUNG." A PNEUMOTHORAX OCCURRED. ADDITIONAL INFORMATION RECEIVED 25-FEB-2020 STATED THE "NURSE ON THE CORE CORTRAK TEAM WAS ASSISTING. X-RAY CONFIRMED PNEUMOTHORAX OCCURRED." THE USER FACILITY DID NOT REALIZE THERE WAS AN ISSUE UNTIL THE PATIENT BECAME AGITATED A FEW HOURS LATER. AGAIN, AN X-RAY WAS TAKEN AND CONFIRMED A PNEUMOTHORAX. A CHEST TUBE WAS PLACED IN THE PATIENT. THE PATIENT WAS INTUBATED DUE TO RESPIRATORY FAILURE RELATED TO HIS DISEASE. THE PATIENT HAD END STAGE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND DIED, ON (B)(6) 2020 AT 13:50, FROM ISSUES UNRELATED TO THE PNEUMOTHORAX.

  Patient problems: Death; Irritability; Pneumothorax

  MAUDE report 9849317 ↗
• InjuryMar 11, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT "A PNEUMOTHORAX...HAPPENED LAST YEAR PRIOR TO (B)(6) 2019." ADDITIONAL INFORMATION RECEIVED 24-FEB-2020 INDICATED THE DEVICE HAD NOT BEEN USED "BECAUSE IT CAUSED A PNEUMOTHORAX." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Pneumothorax

  MAUDE report 9817332 ↗
• InjuryMar 1, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THE AIRWAY PLACEMENT OF THE DEVICE RESULTED IN THE PATIENT DEVELOPING A PNEUMOTHORAX DURING A CORTRAK PLACEMENT. ADDITIONAL INFORMATION RECEIVED 10-FEB-2020 STATED THE NASOGASTRIC TUBE (NGT) LUNG PLACEMENT OCCURRED . THE NGT WAS PLACED IN THE RIGHT LUNG. THE LUNG PLACEMENT WAS CONFIRMED WITH A POST PROCEDURE X-RAY THAT NOTED THE FEEDING TUBE WAS IN RIGHT LUNG CAUSING A 40% PNEUMOTHORAX. A WAYNE CHEST TUBE, 14 FRENCH, WAS PLACED TO TREAT THE PNEUMOTHORAX ON (B)(6) 2020 AT 1700 AND THE CHEST TUBE WAS REMOVED ON (B)(6) 2020 AT 1600. EVENTUALLY THE PATIENT WAS STABILIZED AND DISCHARGED FROM THE HOSPITAL.

  Patient problems: Pneumothorax

  MAUDE report 9772653 ↗
• InjuryFeb 20, 2020Malposition of Device; Malposition of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE EIGHTH OF EIGHT REPORTS. REFER TO 3011270181-2020-00030 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00031 FOR THE SECOND REPORT . REFER TO 3011270181-2020-00032 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00033 FOR THE FOURTH REPORT. REFER TO 3011270181-2020-00034 FOR THE FIFTH REPORT. REFER TO 3011270181-2020-00035 FOR THE SIXTH REPORT. REFER TO 3011270181-2020-00036 FOR THE SEVENTH REPORT. PER AACN AJCC JAN 2020 PUBLICATION "PNEUMOTHORACES PREVENTED WITH USE OF ELECTROMAGNETIC DEVICE TO PLACE FEEDING TUBES," A PNEUMOTHORAX OCCURRED IN A CASE OF PULMONARY PLACEMENT IN WHICH THE FT [FEEDING TUBE] WAS IMMEDIATELY WITHDRAWN. IN THIS CASE, THE OPERATOR RECOGNIZED LEFT-SIDED PULMONARY PLACEMENT, IMMEDIATELY WITHDREW THE FT, AND REINSERTED THE FT INTO THE JEJUNUM. THE PNEUMOTHORAX WAS IDENTIFIED BY ROUTINE RADIOGRAPHY LESS THAN ONE HOUR AFTER PULMONARY PLACEMENT. NO SIGNS OF RESPIRATORY DISTRESS WERE REPORTED, AND THE PNEUMOTHORAX RESOLVED AFTER INSERTION OF A CHEST TUBE.

  Patient problems: Foreign Body In Patient; Pneumothorax

  MAUDE report 9734886 ↗
• InjuryFeb 20, 2020Malposition of Device; Malposition of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE SEVENTH OF EIGHT REPORTS. REFER TO 3011270181-2020-00030 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00031 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00032 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00033 FOR THE FOURTH REPORT. REFER TO 3011270181-2020-00034 FOR THE FIFTH REPORT. REFER TO 3011270181-2020-00035 FOR THE SIXTH REPORT. REFER TO 3011270181-2020-00037 FOR THE EIGHTH REPORT. PER AACN AJCC JAN 2020 PUBLICATION "PNEUMOTHORACES PREVENTED WITH USE OF ELECTROMAGNETIC DEVICE TO PLACE FEEDING TUBES," A PULMONARY PLACEMENT WAS NOT RECOGNIZED BY CORTRAK OPERATORS AT THE TIME OF FT [FEEDING TUBE] INSERTION. THIS RESULTED IN DELAYED WITHDRAWAL OF THE FEEDING TUBE. PULMONARY PLACEMENT WAS CONFIRMED BY RADIOGRAPHIC IMAGING. RETROSPECTIVE ANALYSIS INDICATED THAT PULMONARY PLACEMENT COULD HAVE BEEN IDENTIFIED ON THE BASIS OF THE CORTRAK INSERTION TRACING IN 4 FTS. THE EMPD [ELECTROMAGNETIC PLACEMENT DEVICE] INSERTION TRACINGS OF 3 FTS WERE DESCRIBED IN THE FOLLOWING WAYS: (1) UNDEFINABLE POSITION ON INSE

  Patient problems: Foreign Body In Patient; No Code Available; Pneumonia

  MAUDE report 9734873 ↗
• MalfunctionFeb 20, 2020Malposition of Device; Malposition of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FOURTH OF EIGHT REPORTS. REFER TO 3011270181-2020-00030 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00031 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00032 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00034 FOR THE FIFTH REPORT. REFER TO 3011270181-2020-00035 FOR THE SIXTH REPORT. REFER TO 3011270181-2020-00036 FOR THE SEVENTH REPORT. REFER TO 3011270181-2020-00037 FOR THE EIGHTH REPORT. PER AACN AJCC JAN 2020 PUBLICATION "PNEUMOTHORACES PREVENTED WITH USE OF ELECTROMAGNETIC DEVICE TO PLACE FEEDING TUBES," A PULMONARY PLACEMENT WAS NOT RECOGNIZED BY CORTRAK OPERATORS AT THE TIME OF FT [FEEDING TUBE] INSERTION. THIS RESULTED IN DELAYED WITHDRAWAL OF THE FEEDING TUBE. PULMONARY PLACEMENT WAS CONFIRMED BY RADIOGRAPHIC IMAGING. RETROSPECTIVE ANALYSIS INDICATED THAT PULMONARY PLACEMENT COULD HAVE BEEN IDENTIFIED ON THE BASIS OF THE CORTRAK INSERTION TRACING IN 4 FTS. THE EMPD [ELECTROMAGNETIC PLACEMENT DEVICE] INSERTION TRACINGS OF 3 FTS WERE DESCRIBED IN THE FOLLOWING WAYS: (1) UNDEFINABLE POSITION ON INSE

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 9734867 ↗
• InjuryFeb 20, 2020Malposition of Device; Malposition of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE SIXTH OF EIGHT REPORTS. REFER TO 3011270181-2020-00030 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00031 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00032 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00033 FOR THE FOURTH REPORT. REFER TO 3011270181-2020-00034 FOR THE FIFTH REPORT. REFER TO 3011270181-2020-00036 FOR THE SEVENTH REPORT. REFER TO 3011270181-2020-00037 FOR THE EIGHTH REPORT. PER AACN AJCC JAN 2020 PUBLICATION "PNEUMOTHORACES PREVENTED WITH USE OF ELECTROMAGNETIC DEVICE TO PLACE FEEDING TUBES," A PULMONARY PLACEMENT WAS NOT RECOGNIZED BY CORTRAK OPERATORS AT THE TIME OF FT [FEEDING TUBE] INSERTION. THIS RESULTED IN DELAYED WITHDRAWAL OF THE FEEDING TUBE. PULMONARY PLACEMENT WAS CONFIRMED BY RADIOGRAPHIC IMAGING. RETROSPECTIVE ANALYSIS INDICATED THAT PULMONARY PLACEMENT COULD HAVE BEEN IDENTIFIED ON THE BASIS OF THE CORTRAK INSERTION TRACING IN 4 FTS. THE EMPD [ELECTROMAGNETIC PLACEMENT DEVICE] INSERTION TRACINGS OF 3 FTS WERE DESCRIBED IN THE FOLLOWING WAYS: (1) UNDEFINABLE POSITION ON INSE

  Patient problems: Pneumothorax

  MAUDE report 9734863 ↗
• InjuryFeb 20, 2020Malposition of Device; Malposition of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIFTH OF EIGHT REPORTS. REFER TO 3011270181-2020-00030 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00031 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00032 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00033 FOR THE FOURTH REPORT. REFER TO 3011270181-2020-00035 FOR THE SIXTH REPORT. REFER TO 3011270181-2020-00036 FOR THE SEVENTH REPORT. REFER TO 3011270181-2020-00037 FOR THE EIGHTH REPORT. PER AACN AJCC JAN 2020 PUBLICATION "PNEUMOTHORACES PREVENTED WITH USE OF ELECTROMAGNETIC DEVICE TO PLACE FEEDING TUBES," A PULMONARY PLACEMENT WAS NOT RECOGNIZED BY CORTRAK OPERATORS AT THE TIME OF FT [FEEDING TUBE] INSERTION. THIS RESULTED IN DELAYED WITHDRAWAL OF THE FEEDING TUBE. PULMONARY PLACEMENT WAS CONFIRMED BY RADIOGRAPHIC IMAGING. RETROSPECTIVE ANALYSIS INDICATED THAT PULMONARY PLACEMENT COULD HAVE BEEN IDENTIFIED ON THE BASIS OF THE CORTRAK INSERTION TRACING IN 4 FTS. THE EMPD [ELECTROMAGNETIC PLACEMENT DEVICE] INSERTION TRACINGS OF 3 FTS WERE DESCRIBED IN THE FOLLOWING WAYS: (1) UNDEFINABLE POSITION ON INSE

  Patient problems: Pneumothorax; Respiratory Distress

  MAUDE report 9734861 ↗
• MalfunctionFeb 20, 2020Malposition of Device; Malposition of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE SECOND OF EIGHT REPORTS. REFER TO 3011270181-2020-00030 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00032 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00033 FOR THE FOURTH REPORT. REFER TO 3011270181-2020-00034 FOR THE FIFTH REPORT. REFER TO 3011270181-2020-00035 FOR THE SIXTH REPORT. REFER TO 3011270181-2020-00036 FOR THE SEVENTH REPORT. REFER TO 3011270181-2020-00037 FOR THE EIGHTH REPORT. PER AACN AJCC JAN 2020 PUBLICATION "PNEUMOTHORACES PREVENTED WITH USE OF ELECTROMAGNETIC DEVICE TO PLACE FEEDING TUBES," A PULMONARY PLACEMENT WAS NOT RECOGNIZED BY CORTRAK OPERATORS AT THE TIME OF FT [FEEDING TUBE] INSERTION. THIS RESULTED IN DELAYED WITHDRAWAL OF THE FEEDING TUBE. PULMONARY PLACEMENT WAS CONFIRMED BY RADIOGRAPHIC IMAGING. RETROSPECTIVE ANALYSIS INDICATED THAT PULMONARY PLACEMENT COULD HAVE BEEN IDENTIFIED ON THE BASIS OF THE CORTRAK INSERTION TRACING IN 4 FTS. THE EMPD [ELECTROMAGNETIC PLACEMENT DEVICE] INSERTION TRACINGS OF 3 FTS WERE DESCRIBED IN THE FOLLOWING WAYS: (1) UNDEFINABLE POSITION ON INSE

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 9732869 ↗
• MalfunctionFeb 20, 2020Malposition of Device; Malposition of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE THIRD OF EIGHT REPORTS. REFER TO 3011270181-2020-00030 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00031 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00033 FOR THE FOURTH REPORT. REFER TO 3011270181-2020-00034 FOR THE FIFTH REPORT. REFER TO 3011270181-2020-00035 FOR THE SIXTH REPORT. REFER TO 3011270181-2020-00036 FOR THE SEVENTH REPORT. REFER TO 3011270181-2020-00037 FOR THE EIGHTH REPORT. PER AACN AJCC JAN 2020 PUBLICATION "PNEUMOTHORACES PREVENTED WITH USE OF ELECTROMAGNETIC DEVICE TO PLACE FEEDING TUBES," A PULMONARY PLACEMENT WAS NOT RECOGNIZED BY CORTRAK OPERATORS AT THE TIME OF FT [FEEDING TUBE] INSERTION. THIS RESULTED IN DELAYED WITHDRAWAL OF THE FEEDING TUBE. PULMONARY PLACEMENT WAS CONFIRMED BY RADIOGRAPHIC IMAGING. RETROSPECTIVE ANALYSIS INDICATED THAT PULMONARY PLACEMENT COULD HAVE BEEN IDENTIFIED ON THE BASIS OF THE CORTRAK INSERTION TRACING IN 4 FTS. THE EMPD [ELECTROMAGNETIC PLACEMENT DEVICE] INSERTION TRACINGS OF 3 FTS WERE DESCRIBED IN THE FOLLOWING WAYS: (1) UNDEFINABLE POSITION ON INSE

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 9732866 ↗
• MalfunctionFeb 20, 2020Malposition of Device; Malposition of Device

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIRST OF EIGHT REPORTS. REFER TO 3011270181-2020-00031 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00032 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00033 FOR THE FOURTH REPORT. REFER TO 3011270181-2020-00034 FOR THE FIFTH REPORT. REFER TO 3011270181-2020-00035 FOR THE SIXTH REPORT. REFER TO 3011270181-2020-00036 FOR THE SEVENTH REPORT. REFER TO 3011270181-2020-00037 FOR THE EIGHTH REPORT. PER AACN AJCC JAN 2020 PUBLICATION "PNEUMOTHORACES PREVENTED WITH USE OF ELECTROMAGNETIC DEVICE TO PLACE FEEDING TUBES," A PULMONARY PLACEMENT WAS NOT RECOGNIZED BY CORTRAK OPERATORS AT THE TIME OF FT [FEEDING TUBE] INSERTION. THIS RESULTED IN DELAYED WITHDRAWAL OF THE FEEDING TUBE. PULMONARY PLACEMENT WAS CONFIRMED BY RADIOGRAPHIC IMAGING. RETROSPECTIVE ANALYSIS INDICATED THAT PULMONARY PLACEMENT COULD HAVE BEEN IDENTIFIED ON THE BASIS OF THE CORTRAK INSERTION TRACING IN 4 FTS. THE EMPD [ELECTROMAGNETIC PLACEMENT DEVICE] INSERTION TRACINGS OF 3 FTS WERE DESCRIBED IN THE FOLLOWING WAYS: (1) UNDEFINABLE POSITION ON INSE

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 9732865 ↗
• InjuryFeb 19, 2020Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION RECEIVED 27-FEB-2020 INDICATED "DUOTUBE PLACED (B)(6) 2020 AT 1700. PLACED USING CORTRAK. MARKING AT NOSE 123CM. WENT IN WITH NO RESISTANCE OR COMPLICATIONS. LEFT LUNG [PLACEMENT]. 2 X-RAYS WERE COMPLETED THE NIGHT OF DUOTUBE PLACEMENT. ONE BEING AT 1720, THE OTHER AT 1927. NEITHER MENTION FEEDING TUBE PLACEMENT. X-RAY COMPLETED ON (B)(6) 2020 AT 1145, POST FEEDING TUBE REMOVAL, NO EVIDENCE OF PNEUMOTHORAX. (B)(6) 2020 AT 0930 CT [COMPUTED TOMOGRAPHY] OF ABDOMEN PERFORMED. TEST THAT FOUND PLACEMENT OF DUOTUBE IN THE LUNG. STATED DUOTUBE RESIDES IN LEFT PLEURAL SPACE. [BRONCHOSCOPY PERFORMED] (B)(6) 2020 AT 1130." CURRENT PATIENT STATUS WAS "DISCHARGED TO SNF [SKILLED NURSING FACILITY]." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Foreign Body In Patient; Pain; Pneumothorax

  MAUDE report 9726546 ↗
• InjuryDec 23, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THE CLINICIANS MISREAD THE GRAPHIC AND PLACED THE NASOGASTRIC (NG) TUBE WAS PLACED TUBE IN THE LUNG. THE PATIENT DEVELOPED A PNEUMOTHORAX. THE NG TUBE WAS REMOVED.NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pneumothorax

  MAUDE report 9511445 ↗
• InjuryNov 21, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THE FEEDING TUBE PERFORATED THE PATIENT¿S HIATAL HERNIA DURING INSERTION ON (B)(6) 2019. IT WAS IDENTIFIED TWO DAYS LATER, ON (B)(6) 2019, WHEN THE PATIENT¿S STOMACH WAS DISTENDED AND A COMPUTED TOMOGRAPHY CT SCAN WAS ORDERED. THE PATIENT REQUIRED EMERGENT SURGICAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED 30-OCT-2019 STATED THE NURSE FREQUENTLY DID CORTRAK RETRACING'S AND ALSO FORGOT TO SELECT "END" BEFORE PULLING THE STYLET OUT. THE RISK MANAGEMENT PERSONNEL DID NOT BLAME THE CLINICIAN OR THE CORTRAK DEVICE FOR THE COMPLICATION. THEY DON¿T KNOW WHEN THE PERFORATION OCCURRED AND IT MAY HAVE BEEN FROM OTHER PROCEDURES. RADIOLOGY ALSO READ THE RADIOLOGY EXAM RESULTS NOTING THE TIP WAS IN THE INCORRECT POSITION. ADDITIONAL INFORMATION RECEIVED 01-NOV-2019 STATING THE PATIENT WAS "STABLE BUT VERY ILL."

  Patient problems: Bowel Perforation

  MAUDE report 9357583 ↗
• InjuryMay 14, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THE NASOGASTRIC (NG) TUBE WAS PLACED USING THE CORTRAK2 AT 12:55PM, THE DEVICE APPEARED TO BE PLACED CORRECTLY. PER THE USER FACILITY'S POLICY, A CHEST X-RAY (CXR) WAS OBTAINED TO FOLLOW PLACEMENT OF THE NG TUBE. THE CXR REVEALED THE WEIGHTED TIP NG FEEDING CATHETER TERMINATED IN THE LOWER LOBE OF THE RIGHT LUNG. THE NG TUBE WAS IMMEDIATELY PULLED BACK, REMOVED AND BLINDLY REINSERTED. A FOLLOW-UP CXR REVEALED PROPER PLACEMENT WAS OBTAINED. THE PATIENT DID NOT HAVE ANY ADVERSE EFFECTS FROM THE BRIEF LUNG PLACEMENT.

  Patient problems: Pneumothorax

  MAUDE report 8609699 ↗
• MalfunctionMay 6, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THE MONITOR IS NOT DISPLAYING THE NASOGASTRIC (NG) TUBE ON THE SCREEN. IF THE CORTRAK DEVICES DOES DISPLAY NG TUBE IT ONLY DISPLAYS THE TIP AND IT DOES NOT REFLECT THE ENTIRE PATH TAKEN THE NG TUBE ON THE DISPLAY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8584424 ↗
• DeathMay 1, 2019Malposition of Device; Malposition of Device

  CLARIFICATION OF THE EVENT DESCRIPTION IS AS FOLLOWS: AN UNKNOWN FEEDING TUBE WAS USED WITH THE CORTRAK EAS (ENTERAL ACCESS SYSTEM). THE UNKNOWN FEEDING TUBE WAS INSERTED INTO THE PATIENT'S LUNG. THE CORTRAK EAS CONFIRMS BEDSIDE TUBE PLACEMENTS WITHOUT X-RAY.

  Patient problems: Death; Perforation; Pneumothorax

  MAUDE report 8571343 ↗
• MalfunctionMar 2, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED A NURSE FROM THE NIGHT-SHIFT CALLED REQUESTING TO VIEW PLACED FILES AS THEY WANTED TO VIEW AN INCIDENT OF LUNG PLACEMENT. THE CLINICIANS REPORTED THE TUBE ENTERED THE LUNG AND WAS IMMEDIATELY REMOVED WITHOUT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8384518 ↗
• InjuryFeb 12, 2019Malposition of Device; Malposition of Device

  PER ADDITIONAL INFORMATION RECEIVED 4 APR 2019, THE PATIENT'S CARDIAC ARREST WAS NOT CAUSED BY THE LUNG PLACEMENT. THE REP DETERMINED THAT THE NURSE WHO WAS RE-INSERTING THE GUIDEWIRE WAS NOT USING IT CORRECTLY, AND THEREFORE THE REP GAVE THE NURSE FULL CORTRAK TRAINING, TO PREVENT RECURRENCE OF THE ISSUE. THE TIMELINE OF EVENTS THAT OCCURRED ARE AS FOLLOWS: ON (B)(6) 2019, NURSE B INSERTED THE PATIENT'S FIRST NASOGASTRIC (NG) TUBE USING THE CORTRAK DEVICE. FOUR ATTEMPTS WERE MADE TO PLACE THIS TUBE, AND PLACEMENT WAS CONFIRMED AS CORRECT VIA X-RAY. IN THE EVENING, THE PATIENT PULLED OUT THE NG TUBE, AND WAS NOT FED OVERNIGHT. ON (B)(6) 2019, NURSE C INSERTED ANOTHER NG TUBE BUT WAS UNABLE TO GET ASPIRATE. THIS TUBE WAS NOT PLACED USING THE CORTRAK DEVICE, AS IT WAS A CORFLO NG TUBE (NON-CORTRAK). THE DOCUMENTATION FOR THIS NEW TUBE WAS NOT PUT IN THE CORRECT PLACE AND WAS THEREFORE NOT SEEN BY ALL STAFF, LEADING SOME TO BE UNDER THE IMPRESSION THAT THIS CORFLO TUBE WAS THE ORIGINAL COTRACK TUBE PLACED ON (B)(6) 2019. NURSE D AND NURSE A DID ADDITIONAL PH TESTS ON ASPIRATE TO CONFIRM PLACEMENT OF THE NG TUBE, BUT THE RESULTS WERE TOO HIGH AND WERE THEREFORE NOT USED. NURSE A, WHO A

  Patient problems: Cardiac Arrest; Pneumothorax

  MAUDE report 8332219 ↗
• InjuryFeb 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A USER ENCOUNTERED A LUNG PLACEMENT THAT CAUSED HARM TO A PATIENT ASSOCIATED WITH THE USE OF A CORTRAK DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8302151 ↗
• InjuryFeb 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A USER ENCOUNTERED A LUNG PLACEMENT THAT CAUSED HARM TO A PATIENT ASSOCIATED WITH THE USE OF A CORTRAK DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8302146 ↗