Ballard* Turbo-Cleaning Closed Suction System 93839Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00609038938394), received between Jul 1, 2020 and Feb 18, 2022 — classified as 1 death, 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (21 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030647-2022-00058 FOR THE FIRST REPORT. REFER TO 8030647-2022-00059 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE CUSTOMER WAS HAVING AN ISSUE WITH THE INLINE SUCTION CATHETER. THE CATHETER APPEARED TO BE BLOCKED AS THE CUSTOMER STATED THEY WERE UNABLE TO GET ANY FLOW PAST THE SWITCH. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13564110 ↗
• MalfunctionFeb 18, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030647-2022-00059 FOR THE SECOND REPORT. REFER TO 8030647-2022-00060 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE CUSTOMER WAS HAVING AN ISSUE WITH THE INLINE SUCTION CATHETER. THE CATHETER APPEARED TO BE BLOCKED AS THE CUSTOMER STATED THEY WERE UNABLE TO GET ANY FLOW PAST THE SWITCH. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13564100 ↗
• MalfunctionFeb 18, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 8030647-2022-00058 FOR THE FIRST REPORT. REFER TO 8030647-2022-00060 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE CUSTOMER WAS HAVING AN ISSUE WITH THE INLINE SUCTION CATHETER. THE CATHETER APPEARED TO BE BLOCKED AS THE CUSTOMER STATED THEY WERE UNABLE TO GET ANY FLOW PAST THE SWITCH. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13564098 ↗
• MalfunctionFeb 17, 2022Suction Failure; Suction Failure

  IT WAS REPORTED THAT PATIENT'S CATHETER HAD ABSOLUTELY NO SUCTION WHEN THE BUTTON WAS PRESSED WHILE SUCTIONING. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13550060 ↗
• MalfunctionFeb 14, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2022-00042 FOR THE FIRST REPORT. IT WAS REPORTED THAT UPON INITIAL PLACEMENT THE CLOSED SUCTION CATHETER (CSC) WOULD NOT SUCTION. THE DEVICE WAS REPLACED AND THE PATIENT WAS SUCTIONED WITHOUT DIFFICULTY. THERE WAS NO REPORTED RESPIRATORY DECLINE AND NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529567 ↗
• MalfunctionFeb 14, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2022-00043 FOR THE SECOND REPORT. IT WAS REPORTED THAT UPON INITIAL PLACEMENT THE CLOSED SUCTION CATHETER (CSC) WOULD NOT SUCTION. THE DEVICE WAS REPLACED AND THE PATIENT WAS SUCTIONED WITHOUT DIFFICULTY. THERE WAS NO REPORTED RESPIRATORY DECLINE AND NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529564 ↗
• MalfunctionFeb 10, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030647-2022-00047 FOR THE FIRST EVENT. REFER TO 8030647-2022-00048 FOR THE SECOND EVENT. IT WAS REPORTED DURING PATIENT USE THERE WAS ABSOLUTELY NO SUCTION WHEN THE CLOSED SUCTION CATHETER BUTTON WAS PRESSED WHILE SUCTIONING. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13509459 ↗
• MalfunctionFeb 10, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 8030647-2022-00047 FOR THE FIRST EVENT. REFER TO 8030647-2022-00049 FOR THE THIRD EVENT. IT WAS REPORTED DURING PATIENT USE THERE WAS ABSOLUTELY NO SUCTION WHEN THE CLOSED SUCTION CATHETER BUTTON WAS PRESSED WHILE SUCTIONING. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13509456 ↗
• MalfunctionFeb 10, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030647-2022-00048 FOR THE SECOND EVENT. REFER TO 8030647-2022-00049 FOR THE THIRD EVENT. IT WAS REPORTED DURING PATIENT USE THERE WAS ABSOLUTELY NO SUCTION WHEN THE CLOSED SUCTION CATHETER BUTTON WAS PRESSED WHILE SUCTIONING. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13509453 ↗
• MalfunctionFeb 7, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH INVOLVED TWO SEPARATE UNITS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2022-00028 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE THERAPIST ATTEMPTED TO SUCTION THE PATIENT USING A NEW CATHETER AND THE SUCTION DID NOT WORK. THERE WAS NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13476508 ↗
• MalfunctionFeb 4, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH INVOLVED TWO SEPARATE UNITS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2022-00028 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE THERAPIST ATTEMPTED TO SUCTION THE PATIENT USING A NEW CATHETER AND THE SUCTION DID NOT WORK. THERE WAS NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13455815 ↗
• MalfunctionFeb 4, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH INVOLVED TWO SEPARATE UNITS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2022-00027 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE THERAPIST ATTEMPTED TO SUCTION THE PATIENT USING A NEW CATHETER AND THE SUCTION DID NOT WORK. THERE WAS NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13455798 ↗
• MalfunctionFeb 4, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE EIGHTH OF EIGHT REPORTS. REFER TO 8030647-2022-00030 FOR THE FIRST REPORT. REFER TO 8030647-2022-00031 FOR THE SECOND REPORT. REFER TO 8030647-2022-00032 FOR THE THIRD REPORT. REFER TO 8030647-2022-00033 FOR THE FOURTH REPORT. REFER TO 8030647-2022-00034 FOR THE FIFTH REPORT. REFER TO 8030647-2022-00035 FOR THE SIXTH REPORT. REFER TO 8030647-2022-00036 FOR THE SEVENTH REPORT. IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER (CSC) FAILED TO SUCTION. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED, 21JAN2022 STATING THE CSC WAS USED ON A PATIENT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454799 ↗
• MalfunctionFeb 4, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SEVENTH OF EIGHT REPORTS. REFER TO 8030647-2022-00030 FOR THE FIRST REPORT. REFER TO 8030647-2022-00031 FOR THE SECOND REPORT. REFER TO 8030647-2022-00032 FOR THE THIRD REPORT. REFER TO 8030647-2022-00033 FOR THE FOURTH REPORT. REFER TO 8030647-2022-00034 FOR THE FIFTH REPORT. REFER TO 8030647-2022-00035 FOR THE SIXTH REPORT. REFER TO 8030647-2022-00037 FOR THE EIGHT REPORT. IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER (CSC) FAILED TO SUCTION. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED, 21JAN2022 STATING THE CSC WAS USED ON A PATIENT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454798 ↗
• MalfunctionFeb 4, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIFTH OF EIGHT REPORTS. REFER TO 8030647-2022-00030 FOR THE FIRST REPORT. REFER TO 8030647-2022-00031 FOR THE SECOND REPORT. REFER TO 8030647-2022-00032 FOR THE THIRD REPORT. REFER TO 8030647-2022-00033 FOR THE FOURTH REPORT. REFER TO 8030647-2022-00035 FOR THE SIXTH REPORT. REFER TO 8030647-2022-00036 FOR THE SEVENTH REPORT. REFER TO 8030647-2022-00037 FOR THE EIGHT REPORT. IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER (CSC) FAILED TO SUCTION. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED, 21JAN2022 STATING THE CSC WAS USED ON A PATIENT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454796 ↗
• MalfunctionFeb 4, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FOURTH OF EIGHT REPORTS. REFER TO 8030647-2022-00030 FOR THE FIRST REPORT. REFER TO 8030647-2022-00031 FOR THE SECOND REPORT. REFER TO 8030647-2022-00032 FOR THE THIRD REPORT. REFER TO 8030647-2022-00034 FOR THE FIFTH REPORT. REFER TO 8030647-2022-00035 FOR THE SIXTH REPORT. REFER TO 8030647-2022-00036 FOR THE SEVENTH REPORT. REFER TO 8030647-2022-00037 FOR THE EIGHT REPORT. IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER (CSC) FAILED TO SUCTION. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED, (B)(6) 2022 STATING THE CSC WAS USED ON A PATIENT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454791 ↗
• MalfunctionFeb 4, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SIXTH OF EIGHT REPORTS. REFER TO 8030647-2022-00030 FOR THE FIRST REPORT. REFER TO 8030647-2022-00031 FOR THE SECOND REPORT. REFER TO 8030647-2022-00032 FOR THE THIRD REPORT. REFER TO 8030647-2022-00033 FOR THE FOURTH REPORT. REFER TO 8030647-2022-00034 FOR THE FIFTH REPORT. REFER TO 8030647-2022-00036 FOR THE SEVENTH REPORT. REFER TO 8030647-2022-00037 FOR THE EIGHT REPORT. IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER (CSC) FAILED TO SUCTION. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED, 21JAN2022 STATING THE CSC WAS USED ON A PATIENT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454786 ↗
• MalfunctionFeb 4, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE THIRD OF EIGHT REPORTS. REFER TO 8030647-2022-00030 FOR THE FIRST REPORT. REFER TO 8030647-2022-00031 FOR THE SECOND REPORT. REFER TO 8030647-2022-00033 FOR THE FOURTH REPORT. REFER TO 8030647-2022-00034 FOR THE FIFTH REPORT. REFER TO 8030647-2022-00035 FOR THE SIXTH REPORT. REFER TO 8030647-2022-00036 FOR THE SEVENTH REPORT. REFER TO 8030647-2022-00037 FOR THE EIGHT REPORT. IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER (CSC) FAILED TO SUCTION. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED, 21JAN2022 STATING THE CSC WAS USED ON A PATIENT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454773 ↗
• MalfunctionFeb 4, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED EIGHT DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF EIGHT REPORTS. REFER TO 8030647-2022-00030 FOR THE FIRST REPORT. REFER TO 8030647-2022-00032 FOR THE THIRD REPORT. REFER TO 8030647-2022-00033 FOR THE FOURTH REPORT. REFER TO 8030647-2022-00034 FOR THE FIFTH REPORT. REFER TO 8030647-2022-00035 FOR THE SIXTH REPORT. REFER TO 8030647-2022-00036 FOR THE SEVENTH REPORT. REFER TO 8030647-2022-00037 FOR THE EIGHT REPORT. IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER (CSC) FAILED TO SUCTION. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED, 21JAN2022 STATING THE CSC WAS USED ON A PATIENT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454771 ↗
• MalfunctionFeb 4, 2022Suction Problem; Suction Problem

  ADDITIONAL INFORMATION RECEIVED 04-FEB-2022 REPORTED THE INCIDENT OCCURRED (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454762 ↗
• MalfunctionDec 22, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2021, "WHILE THE RESPIRATORY THERAPIST (RT ) WAS SUCTIONING A VENTED PATIENT, THE SPRING ON THE LOCK THUMB PORT MALFUNCTIONED AND NEVER SPRUNG UP AND GOT STUCK IN PLACE. THE TIDAL VOLUME DROPPED TO 100CC." NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13064276 ↗
• DeathJul 1, 2020Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 8030647-2020-00038 FOR THE FIRST REPORT. REFER TO 8030647-2020-00039 FOR THE SECOND REPORT. REFER TO 8030647-2020-00040 FOR THE THIRD REPORT. REFER TO 8030647-2020-00041 FOR THE FOURTH REPORT. IT WAS REPORTED THAT THE "ET [ENDOTRACHEAL] TUBE [ETT] CLOGGED WITH TENACIOUS SECRETIONS." ADDITIONAL INFORMATION RECEIVED 16-JUN-2020 INDICATED THE PATIENT WAS ADMITTED AND INTUBATED ON (B)(6) 2020. ON (B)(6) 2020 PATIENT HAD "INCREASED DRIVING PRESSURES, NOT RETURNED TO HIS VT [TIDAL VOLUME], UNABLE TO PASS AN INLINE SUCTION CATHETER THROUGH ETT. VENTILATOR REMOVED, PATIENT BAGGED WITH 100% O2 [OXYGEN]. STRAIGHT SUCTION CATHETER PASSED WITH DIFFICULTY THROUGH ETT. MODERATE AMOUNT OF THICK BLOODY PLUGS REMOVED. PATIENT PLACED BACK ON VENTILATOR WITHOUT DIFFICULTY." THE USER FACILITY STATED "YOU CAN HEAR THE SECRETIONS 'RATTLING' EVEN THOUGH YOU HAVE JUST OR IN THE PROCESS OF SUCTIONING. IN SOME INSTANCES THEY DON'T GET ANYTHING OUT BUT CAN HEAR IT. SOMETIMES THEY WILL REMOVE THE PATIEN

  Patient problems: Death; Respiratory Distress

  MAUDE report 10217916 ↗
• MalfunctionJul 1, 2020Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 8030647-2020-00038 FOR THE FIRST REPORT . REFER TO 8030647-2020-00039 FOR THE SECOND REPORT. REFER TO 8030647-2020-00040 FOR THE THIRD REPORT. REFER TO 8030647-2020-00042 FOR THE FIFTH REPORT. IT WAS REPORTED THAT THE "ET [ENDOTRACHEAL] TUBE [ETT] CLOGGED WITH TENACIOUS SECRETIONS." NO SPECIFIC INFORMATION WAS PROVIDED FOR THIS PATIENT. ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2020. THE USER FACILITY STATED "YOU CAN HEAR THE SECRETIONS 'RATTLING' EVEN THOUGH YOU HAVE JUST OR IN THE PROCESS OF SUCTIONING. IN SOME INSTANCES THEY DON'T GET ANYTHING OUT BUT CAN HEAR IT. SOMETIMES THEY WILL REMOVE THE PATIENT FROM THE VENT AND STRAIGHT CATH THEM TO GET THE SECRETIONS. IN SOME INSTANCES WHEN WE ARE NOT GETTING THE SECRETIONS THE XRAY IS NOT IMPROVING AND O2 [OXYGEN] REQUIREMENTS NOT IMPROVING THEY WILL BRONCH [BRONCHOSCOPY] THE PATIENTS AND WILL GET TONS OF SECRETIONS WITH PLUGS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10217912 ↗
• InjuryJul 1, 2020Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 8030647-2020-00039 FOR THE SECOND REPORT, REFER TO 8030647-2020-00040 FOR THE THIRD REPORT, REFER TO 8030647-2020-00041 FOR THE FOURTH REPORT, REFER TO 8030647-2020-00042 FOR THE FIFTH REPORT. IT WAS REPORTED THAT THE "ET [ENDOTRACHEAL] TUBE [ETT] CLOGGED WITH TENACIOUS SECRETIONS." ADDITIONAL INFORMATION RECEIVED 16-JUN-2020 INDICATED THAT YELLOW, DRIED SECRETIONS WERE ADHERED TO THE INSIDE OF THE ETT. THE PATIENT WAS ADMITTED ON (B)(6) 2020, INTUBATED ON (B)(6) 2020, AND TRANSFERRED TO ANOTHER FACILITY ON (B)(6) 2020. PATIENT WAS ON A HEATED VENT CIRCUIT SINCE INTUBATION. A FIBEROPTIC BRONCHOSCOPY WAS PERFORMED (B)(6) 2020. "INITIALLY PATIENT HAD OBSTRUCTED ET TUBE WITH HARD CRUSTED PARTICLES THAT COULD NOT BE REMOVED WITH SUCTION. ET TUBE WAS EXCHANGED WITH GLIDESCOPE BY ANESTHESIA. BRONCHOSCOPE WAS INTRODUCED WITH FINDINGS ON 2ND BRONCHOSCOPY SHOWING: NORMAL ENDOBRONCHIAL TREE WITH THICKENED CARINA OF RIGHT MIDDLE LOBE POSSIBLY SECONDARY TO BRONCHOMALACIA, THICK BILATERAL

  Patient problems: Inflammation; Respiratory Distress

  MAUDE report 10217911 ↗
• MalfunctionJul 1, 2020Suction Problem; Obstruction of Flow; Suction Problem; Obstruction of Flow

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 8030647-2020-00038 FOR THE FIRST REPORT. REFER TO 8030647-2020-00039 FOR THE SECOND REPORT. REFER TO 8030647-2020-00041 FOR THE FOURTH REPORT. REFER TO 8030647-2020-00042 FOR THE FIFTH REPORT. IT WAS REPORTED THAT THE "ET [ENDOTRACHEAL] TUBE [ETT] CLOGGED WITH TENACIOUS SECRETIONS." NO SPECIFIC INFORMATION WAS PROVIDED FOR THIS PATIENT. ADDITIONAL INFORMATION WAS RECEIVED 16-JUN-2020. THE USER FACILITY STATED "YOU CAN HEAR THE SECRETIONS 'RATTLING' EVEN THOUGH YOU HAVE JUST OR IN THE PROCESS OF SUCTIONING. IN SOME INSTANCES THEY DON'T GET ANYTHING OUT BUT CAN HEAR IT. SOMETIMES THEY WILL REMOVE THE PATIENT FROM THE VENT AND STRAIGHT CATH THEM TO GET THE SECRETIONS....IN SOME INSTANCES WHEN WE ARE NOT GETTING THE SECRETIONS THE XRAY IS NOT IMPROVING AND O2 [OXYGEN] REQUIREMENTS NOT IMPROVING THEY WILL BRONCH [BRONCHOSCOPY] THE PATIENTS AND WILL GET TONS OF SECRETIONS WITH PLUGS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10217909 ↗