Halyard 13220Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 10680651132205), received between Mar 27, 2017 and Dec 21, 2022 — classified as 2 deaths, 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Disconnection” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionDec 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THE "PILOT BALLOON'S LINE SNAPPED." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16024024 ↗
• DeathFeb 17, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE "ETT [ENDOTRACHEAL TUBE] CUFF HAD A LEAK. THE PATIENT CODED AND DID NOT MAKE IT." ADDITIONAL INFORMATION RECEIVED 06-FEB-2020 INDICATED THE DEVICE WAS USED ON AN ADULT DURING CARDIAC ARREST. THE TUBE WAS CHECKED PRIOR TO USE, HOWEVER, THE CUFF HAD TO BE REFILLED NUMEROUS TIMES WHEN IN PLACE. FINALLY THE SYRINGE WAS HELD ON THE PILOT BALLOON TO MAINTAIN A SEAL. THE USER FACILITY NOTICED A SUBSTANTIAL LEAK WHEN THEY DID NOT MANUALLY ENSURE THAT THE PILOT WAS SEALED. THE PATIENT WAS MANUALLY VENTILATED WITH A BMV [BAG MASK VENTILATION]. THE LEAK WAS OBVIOUS DURING POSITIVE PRESSURE VENTILATION WITH THE BMV. THE ETT WAS RECHECKED FOR POSITIONING WHICH CONFIRMED GOOD PLACEMENT. THE USER FACILITY STATED THEY WERE ABLE TO ADEQUATELY VENTILATE WHEN ENSURING THAT THE PILOT WAS SEALED WITH A SYRINGE THAT WAS HELD IN PLACE AND THE PLUNGER KEPT DEPRESSED. THE PATIENT WAS ADEQUATELY VENTILATED DURING THE ARREST BUT "ONLY WITH OUR INTERVENTION WITH THE SYRINGE." ADDITIONAL INFORMATION RECEIVED 07-FEB-2020 INDICATED THE PATIENT DID NOT "CODE" AS A RESULT OF THE CUFF LEAKING. THE USER FACILITY STATED "IT WAS ONLY DURING THE CODE EVENT WITH THE PATIENT THAT IT WAS NOTED THA

  Patient problems: Death

  MAUDE report 9716327 ↗
• MalfunctionJul 5, 2019Disconnection; Disconnection

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 9611594-2019-00122 FOR THE FIRST EVENT. REFER TO 9611594-2019-00123 FOR THE SECOND EVENT. REFER TO 9611594-2019-00124 FOR THE THIRD EVENT. THE ADAPTER ON THE ENDOTRACHEAL TUBE (ETT) ADAPTER POPPED DURING USE. SOMETIMES THIS OCCURRED WITHIN 20-MINUTES OF THE ETT BEING PLACED. THE RESPIRATORY THERAPISTS WERE TAPING THE ADAPTERS IN PLACE TO PREVENT "POP OFF." THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8764388 ↗
• MalfunctionJul 5, 2019Disconnection; Disconnection

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 9611594-2019-00122 FOR THE FIRST EVENT. REFER TO 9611594-2019-00123 FOR THE SECOND EVENT. REFER TO 9611594-2019-00125 FOR THE FOURTH EVENT. THE ADAPTER ON THE ENDOTRACHEAL TUBE (ETT) ADAPTER POPPED DURING USE. SOMETIMES THIS OCCURRED WITHIN 20-MINUTES OF THE ETT BEING PLACED. THE RESPIRATORY THERAPISTS WERE TAPING THE ADAPTERS IN PLACE TO PREVENT "POP OFF." THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8764377 ↗
• MalfunctionJul 5, 2019Disconnection; Disconnection

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 9611594-2019-00122 FOR THE FIRST EVENT. REFER TO 9611594-2019-00124 FOR THE THIRD EVENT. REFER TO 9611594-2019-00125 FOR THE FOURTH EVENT. THE ADAPTER ON THE ENDOTRACHEAL TUBE (ETT) ADAPTER POPPED DURING USE. SOMETIMES THIS OCCURRED WITHIN 20-MINUTES OF THE ETT BEING PLACED. THE RESPIRATORY THERAPISTS WERE TAPING THE ADAPTERS IN PLACE TO PREVENT "POP OFF." THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8764371 ↗
• MalfunctionJul 5, 2019Disconnection; Disconnection

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 9611594-2019-00123 FOR THE SECOND EVENT. REFER TO 9611594-2019-00124 FOR THE THIRD EVENT. REFER TO 9611594-2019-00125 FOR THE FOURTH EVENT. THE ADAPTER ON THE ENDOTRACHEAL TUBE (ETT) ADAPTER POPPED DURING USE. SOMETIMES THIS OCCURRED WITHIN 20-MINUTES OF THE ETT BEING PLACED. THE RESPIRATORY THERAPISTS WERE TAPING THE ADAPTERS IN PLACE TO PREVENT "POP OFF." THERE WAS NO REPORTED INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8764370 ↗
• MalfunctionMay 30, 2019Connection Problem; Connection Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2019-00096 FOR THE FIRST REPORT. REFER TO 9611594-2019-00115 FOR THE THIRD REPORT. IT WAS REPORTED ON 25-APR-2019 THAT "THE 'BLUE' HUB/CONNECTOR ON THE END OF THE SUBGLOTTIC ET [ENDOTRACHEAL] TUBE WHICH CONNECTS THE SUBGLOTTIC ET TUBE TO THE VENTILATOR COMES LOOSE/APART, THEREFORE BREAKING THE CIRCUIT." ADDITIONAL INFORMATION RECEIVED ON 30-APR-2019 INDICATED THERE WAS NO DIRECT PATIENT INJURY THAT THE USER FACILITY IS AWARE OF. THE USER FACILITY STATED THAT "MANY" OF THE REPORTED MODEL CODE HAVE BEEN AFFECTED. LOT NUMBERS ARE UNKNOWN. THE USER FACILITY STATED "WE WILL ASK THERAPISTS TO KEEP THE PACKAGING MOVING FORWARD SO WE CAN TRY AND GET LOT NUMBERS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8656378 ↗
• MalfunctionMay 30, 2019Connection Problem; Connection Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2019-00096 FOR THE FIRST REPORT. REFER TO 9611594-2019-00114 FOR THE SECOND REPORT. IT WAS REPORTED ON 25-APR-2019 THAT "THE 'BLUE' HUB/CONNECTOR ON THE END OF THE SUBGLOTTIC ET [ENDOTRACHEAL] TUBE WHICH CONNECTS THE SUBGLOTTIC ET TUBE TO THE VENTILATOR COMES LOOSE/APART, THEREFORE BREAKING THE CIRCUIT." ADDITIONAL INFORMATION RECEIVED ON 30-APR-2019 INDICATED THERE WAS NO DIRECT PATIENT INJURY THAT THE USER FACILITY IS AWARE OF. THE USER FACILITY STATED THAT "MANY" OF THE REPORTED MODEL CODE HAVE BEEN AFFECTED. LOT NUMBERS ARE UNKNOWN. THE USER FACILITY STATED "WE WILL ASK THERAPISTS TO KEEP THE PACKAGING MOVING FORWARD SO WE CAN TRY AND GET LOT NUMBERS."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8656375 ↗
• MalfunctionMay 29, 2019Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THERE WAS "ETT [ENDOTRACHEAL TUBE] CUFF FAILURE...PATIENT WAS RSI'D [RAPID SEQUENCE INTUBATION]; CONTROLLED INTUBATION. CUFF CHECKED PRIOR TO INTUBATION, WOULD HOLD PRESSURE. AFTER INTUBATION, WOULD NOT HOLD PRESSURE. RE-INTUBATED WITHOUT INCIDENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8649232 ↗
• MalfunctionMay 21, 2019Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2019-00098 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE "BLUE VENT CONNECTOR HAS COME OFF...UNTIL THEY REALIZED THAT THEY HAD TO SEAT THE CONNECTOR TO PREVENT DISCONNECTION DURING USE. ONCE THEY KNEW TO FIRMLY SEAT, NO MORE ISSUES OCCURRED." NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8627118 ↗
• MalfunctionMay 21, 2019Disconnection; Disconnection

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2019-00097 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE "BLUE VENT CONNECTOR HAS COME OFF...UNTIL THEY REALIZED THAT THEY HAD TO SEAT THE CONNECTOR TO PREVENT DISCONNECTION DURING USE. ONCE THEY KNEW TO FIRMLY SEAT, NO MORE ISSUES OCCURRED." NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8627117 ↗
• MalfunctionMay 15, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT "THE 'BLUE' HUB/CONNECTOR ON THE END OF THE SUBGLOTTIC ET [ENDOTRACHEAL] TUBE WHICH CONNECTS THE SUBGLOTTIC ET TUBE TO THE VENTILATOR COMES LOOSE/APART, THEREFORE BREAKING THE CIRCUIT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8611959 ↗
• InjuryApr 24, 2019Gas/Air Leak; Gas/Air Leak

  A MEDWATCH REPORT, (B)(4), WAS RECEIVED RECEIVED ON 02-APR-2019, AND THE FOLLOWING INFORMATION WAS PROVIDED: A PATIENT IN THE ICU DEVELOPED A SEVERE SUBGLOTTIC TUBE CUFF LEAK ON THE OVERNIGHT SHIFT RESULTING IN THE NEED TO REPLACE THE ENDOTRACHEAL TUBE WITH SIGNIFICANT DIFFICULTY. THE SUBGLOTTIC ENDOTRACHEAL TUBE HAD BEEN IN PLACE FOR SEVERAL DAYS PRIOR TO THE EVENT. THE CLINICAL TEAM ATTEMPTED TO RESOLVE THE ISSUE BY RE-INFLATING THE BALLOON AND OCCLUDING THE PORT USED TO FILL THE BALLOON IN CASE IT WAS LEAKING. NEITHER OF THESE INTERVENTIONS WAS SUCCESSFUL AND THE CLINICAL TEAM FEELS THE TRACHEAL BALLOON HAD FAILED DURING ROUTINE USE. THE ENDOTRACHEAL TUBE WAS ULTIMATELY REPLACED BUT LEAD TO SIGNIFICANT HYPOXIA THAT RESOLVED ONCE THE TUBE WAS REPLACED. THE PATIENT HAS SUBSEQUENTLY HAD A FORMAL TRACHEOSTOMY DUE TO PROLONGED RESPIRATORY FAILURE." NO SAMPLE AVAILABLE-SW

  Patient problems: Hypoxia

  MAUDE report 8547236 ↗
• MalfunctionNov 8, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THE MICROCUFF BURST DURING USE. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 25-OCT-2018 STATED THE DEVICE WAS LEAKING JUST AFTER INTUBATION. ALL THE PROTOCOLS WERE FOLLOWED AND PRECAUTIONS WERE TAKEN WHILE INTUBATING THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8052865 ↗
• MalfunctionSep 20, 2018Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2018-00151 FOR THE FIRST PATIENT. REFER TO 9611594-2018-00152 FOR THE SECOND PATIENT. IT WAS REPORTED THAT A CUFF BROKE DURING USE. DURING ENDOTRACHEAL TUBE (ET) REPLACEMENT A DAY AFTER STARTING VENTILATION, THE CUFF PRESSURE CONTROLLER DID NOT STABILIZE. THE PATIENT WAS EXTUBATED AND THE CUFF WAS FOUND TO BE BROKEN. A NEW ET WAS PLACED FOR THE PATIENT WITH NO INJURY TO THE PATIENT NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7895215 ↗
• MalfunctionSep 20, 2018Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2018-00151 FOR THE FIRST PATIENT. REFER TO 9611594-2018-00153 FOR THE THIRD PATIENT. IT WAS REPORTED THAT A CUFF BROKE DURING USE. DURING ENDOTRACHEAL TUBE (ET) REPLACEMENT A DAY AFTER STARTING VENTILATION, THE CUFF PRESSURE CONTROLLER DID NOT STABILIZE. THE PATIENT WAS EXTUBATED AND THE CUFF WAS FOUND TO BE BROKEN. A NEW ET WAS PLACED FOR THE PATIENT WITH NO INJURY TO THE PATIENT NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7895213 ↗
• MalfunctionSep 20, 2018Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2018-00152 FOR THE SECOND PATIENT. REFER TO 9611594-2018-00153 FOR THE THIRD PATIENT. IT WAS REPORTED THAT A CUFF BROKE DURING USE. DURING ENDOTRACHEAL TUBE (ET) REPLACEMENT A DAY AFTER STARTING VENTILATION, THE CUFF PRESSURE CONTROLLER DID NOT STABILIZE. THE PATIENT WAS EXTUBATED AND THE CUFF WAS FOUND TO BE BROKEN. A NEW ET WAS PLACED FOR THE PATIENT WITH NO INJURY TO THE PATIENT NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7895210 ↗
• MalfunctionSep 20, 2018Break; Break

  IT WAS REPORTED THAT THE SUCTION PORT BROKE DURING THE SUCTION PROCESS. THE PATIENT WAS CONSEQUENTLY EXTUBATED AND RE-INTUBATED WITH A NEW ENDOTRACHEAL TUBE. THE EVENT OCCURRED AFTER THREE WEEKS OF USAGE. IT WAS NOTED BY THE NURSE THAT SHE DID NOT APPLY ANY FORCE DURING THE SUCTION PROCESS, AND THE SUCTION PORT BROKE WITHOUT HER REALIZING IT. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7893004 ↗
• MalfunctionAug 24, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF OF THE MICROCUFF ENDOTRACHEAL TUBE (ET) DID NOT INFLATE. THE USER STATED THAT AFTER THE PATIENT WAS INTUBATED, ATTEMPTS WERE MADE TO INFLATE THE CUFF, BUT IT DID NOT INFLATE. THE ET TUBE WAS EXCHANGED FOR ANOTHER WITH NO PATIENT INJURY. THE USER NOTED THAT IT COULD HAVE POSSIBLY BEEN DUE TO A DEFECT WITH THE INFLATION PORT ON THE ET TUBE OR THAT THE CUFF WAS DAMAGED BY THE PATIENT'S TEETH DURING INTUBATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7812465 ↗
• MalfunctionMar 22, 2018Air Leak; Air Leak

  IT WAS REPORTED THAT AFTER A PATIENT WAS INTUBATED THE CUFF WOULD NOT HOLD AIR. (NEW MICROCUFF ENDOTRACHAEL TUBE WAS CHECKED AND THEN PLACED OVER TUBE EXCHANGER). AFTER INTUBATION THE SECOND MICROCUFF CUFF WAS NOT HOLDING AIR. THE ETT WAS REMOVED AND A TEAR WAS FOUND. THE ANESTHESIOLOGIST INTUBATING THE PATIENT ASKED IF PATIENT HAD ANY SHARP TEETH. ANESTHESIA WAS DENIED AND SAID THEY HAD GOOD VIEW. THE PATIENT WAS INTUBATED WITHOUT MICROCUFF THE THIRD TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 27FEB2018 FROM THE CUSTOMER THAT STATED, AN EMERGENT TRACHEAL INTUBATION WAS DONE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 7364295 ↗
• MalfunctionMar 22, 2018Air Leak; Air Leak

  IT WAS REPORTED THAT AFTER A PATIENT WAS INTUBATED THE CUFF WOULD NOT HOLD AIR. (NEW MICROCUFF ENDOTRACHEAL TUBE WAS CHECKED AND THEN PLACED OVER TUBE EXCHANGER). AFTER INTUBATION THE SECOND MICROCUFF CUFF WAS NOT HOLDING AIR. THE ETT WAS REMOVED AND A TEAR WAS FOUND. THE ANESTHESIOLOGIST INTUBATING THE PATIENT ASKED IF PATIENT HAD ANY SHARP TEETH. ANESTHESIA WAS DENIED AND SAID THEY HAD GOOD VIEW. THE PATIENT WAS INTUBATED WITHOUT MICROCUFF THE THIRD TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 27FEB2018 FROM THE CUSTOMER THAT STATED, AN EMERGENT TRACHEAL INTUBATION WAS DONE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 7364266 ↗
• MalfunctionJul 20, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE ADAPTER DISCONNECTS TOO EASILY, RESULTING IN A DISCONNECTION OF THE PATIENT FROM THE VENTILATOR. THIS HAPPENS FREQUENTLY AFTER USING AN AMBU BAG ON THE ADAPTER. PER ADDITIONAL INFORMATION WAS RECEIVED ON 29-JUN-2017, THERE WAS NO PATIENT INJURY AND NO MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6728758 ↗
• DeathJul 14, 2017Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT A PATIENT WITH SEVERE ALCOHOLIC LIVER FAILURE WAS INTUBATED DUE TO ACUTE RESPIRATORY DISTRESS SYNDROME CAUSED BY HYPERCYTOKINEMIA. THE ENDOTRACHEAL TUBE CUFF FUNCTION WAS CONFIRMED BY TWO NURSES PRIOR TO INTUBATION. THE FIRST ATTEMPT TO INTUBATE WAS UNSUCCESSFUL DUE TO PATIENT MUSCLE TONE. THE PATIENT WENT INTO CARDIO-PULMONARY ARREST AT THIS TIME. USING THE SAME DEVICE, THE DOCTOR ATTEMPTED INTUBATION AGAIN DURING RESUSCITATION, HOWEVER THE SECOND ATTEMPT FAILED BECAUSE THE TUBE WAS PLACED IN THE ESOPHAGUS. A THIRD ATTEMPT WITH THE DEVICE WAS SUCCESSFUL AT PLACEMENT, HOWEVER, THE CUFF DID NOT INFLATE. AFTER VENTILATION WAS STARTED WITH A BAG-MASK VALVE, A NURSE NOTED THE SOUND OF AN AIR LEAK. THE PATIENT WAS EXTUBATED AND THE CUFF WAS FOUND TO BE BROKEN. THE NURSE REPORTED THAT THE CUFF MAY HAVE HIT THE PATIENT'S TOOTH DURING THE FIRST INTUBATION. THE PATIENT EXPIRED AN UNKNOWN LENGTH OF TIME AFTER THE REPORTED EVENT. THE DOCTOR REPORTS THAT THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE BROKEN CUFF AND THE PATIENT'S DEATH. ACCORDING TO THE HEAD NURSE, THE PATIENT WAS ALREADY IN SEVERE AND DIFFICULT CONDITION WHEN SHE WAS BROUGHT IN TO THE HOSPITAL. NO FURTHER I

  Patient problems: Death

  MAUDE report 6714917 ↗
• MalfunctionMar 27, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2017-00050 FOR THE FIRST REPORT. IT WAS REPORTED THAT, THE SECOND ISSUE IS THE STUCK SSM BLUE CONNECTOR EITHER IN THE RESUSCITATION BAG ADAPTER OR TRACH CARE SWIVEL ADAPTER. THE CONNECTIONS BECOME SO TIGHT THAT IT TAKES A WEDGE OR KELLEY FORCEPS TO SEPARATE THE BLUE CONNECTOR FROM RESUSCITATION BAG OR TRACH CARE SWIVEL. THIS IS EXTREMELY CONCERNING BECAUSE THE PATIENT CAN'T BE RETURNED TO THE VENTILATOR AFTER RESUSCITATION AND OR THE TRACH CARE CANNOT BE CHANGED EXPEDIENTLY UNTIL THE CONNECTOR IS REMOVED WITH A TOOL THAT IS OFTEN NOT READILY AVAILABLE. THERE WERE NO PATIENTS INJURED AS A RESULT OF THE REPORTED CONNECTOR DISCONNECTIONS AND/OR STUCK CONNECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6437826 ↗
• MalfunctionMar 27, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2017-00051 FOR THE SECOND REPORT. IT WAS REPORTED THAT THERE IS A 40% DISCONNECT RATE OF THE BLUE CONNECTOR FROM THE SUBGLOTTIC MICROCUFF ET TUBE. THIS CONCERN IS CAUSED BY STRETCHING OF THE PVC SSM TUBE BY THE BLUE CONNECTOR WHICH CAUSES A VERY LOOSE FIT. IN SOME CASES THE FIT IS SO LOOSE THAT THE CONNECTOR SIMPLY FALLS OUT. ADDITIONAL INFORMATION WAS RECEIVED THE SAME DAY, 01-MAR-2017 THAT STATES, THE ICU RESPIRATORY TEAM LEADER DESCRIBES THE CONCERN AS FOLLOWS: "WE HAVE HAD A NUMBER OF MICROCUFF TUBES WHERE THE BLUE ADAPTOR KEEPS COMING OUT EVEN AFTER PUSHING IT IN TO THE HILT. I HAVE ONE NEW TUBE IN MY OFFICE THAT I WANTED TO CHECK MYSELF. AFTER PUSHING THE BLUE TIP ALL THE WAY IN, IT CAUSES THE TOP PART OF THE TUBE TO EXPAND, WHICH BECOMES THE REAL REASON WHY THE STAFF ARE SEEING THIS MORE. MY CONCERN ABOUT THIS IS WHEN WE ARE TREATING PATIENTS WITH HIGH LEVELS OF OXYGEN AND PEEP, THIS BECOMES A REAL PROBLEM WHEN THEY ARE DISCONNECTED FROM THE VENTILATOR.¿ NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6436196 ↗