Ballard* Closed Suction System 93826Recalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 00609038938264), received between Jan 26, 2022 and Mar 12, 2025 — classified as 8 injuries, 62 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (32 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 19, 2025Open, Classified

   Lack of sterility assurance for closed suction catheter systems

   Z-1521-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED, AFTER TURNING THE PATIENT AN ATTEMPT TO SUCTION WAS MADE WITH A NEWLY REPLACED CLOSED SUCTION CATHETER (CSC); HOWEVER, THE CSC WAS DIFFICULT TO ADVANCE AND THE DECISION WAS MADE TO REPLACE IT WITH A NEW ONE. IT WAS NOTED, THE CSC [APPEARED] TO BE THICKER BETWEEN THE 5-7CM MARKINGS. IT WAS ADDITIONALLY NOTED THAT IT MAY HAVE PREVIOUSLY BEEN SQUISHED BETWEEN SOMETHING; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21585354 ↗
• MalfunctionFeb 13, 2025Break; Break

  BREAKAGE OF THE 'KEY' OF THE CLOSED SUCTION SYSTEM WAS REPORTED, WHICH RESULTED IN DELAYED ASPIRATION (DUE TO TIME TO OBTAIN A NEW TRACHCARE FROM STOCK AND REPLACE IT ON THE PATIENT'S TUBE. IT WAS ADDITIONALLY REPORTED, THERE WAS NO REPORTED INJURY; HOWEVER, POSSIBLE ALVEOLAR RECRUITMENT IN THE CASE OF MECONIUM ASPIRATION IN THE BABY WAS NOTED.

  Patient problems: Insufficient Information

  MAUDE report 21381282 ↗
• MalfunctionFeb 7, 2025Suction Failure; Suction Failure

  IT WAS REPORTED, THE CATHETER WAS UNUSABLE FOR MECONIAL ASPIRATION FOR AN INFANT IN URGENT NEED OF ASPIRATION. THE TRACH CARE WAS CHANGED AS QUICKLY AS POSSIBLE; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21339079 ↗
• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED, DURING INITIAL USE OF THE CLOSED SUCTION CATHETER, THE THUMB CONTROL WAS STUCK IN THE ON POSITION AND WOULD NOT RELEASE, WHICH CAUSED THE SUCTION TO CONTINUE TO DRAW GAS FROM THE ENDOTRACHEAL TUBE (ETT). IT WAS ADDITIONALLY REPORTED, THE VENTILATOR ALARMED; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21060537 ↗
• MalfunctionDec 30, 2024Break; Break

  THE ANESTHESIA TECHNICIAN TEAM LEAD REPORTED, WE HAD AN IN-LINE SUCTION BREAK OFF IN THE ENDOTRACHEAL (ETT), WHILE IT WAS BEING USED ON A PATIENT. THE CLOSED SUCTION SYSTEM HAD TO BE PULLED OFF AND CUT OPEN IN ORDER TO RETRIEVE IT OUT OF THE ETT. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21038980 ↗
• InjuryNov 20, 2023Material Integrity Problem; Material Integrity Problem

  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 8030647-2023-00147 FOR THE FIRST REPORT. IT WAS REPORTED THAT AFTER A NEW CATHETER WAS APPLIED, DURING A SECOND SUCTIONING ATTEMPT, THE CATHETER BROKE AND HAD TO BE CHANGED. THE BREAK CAUSED A LEAK IN THE PATIENT¿S VENTILATION SYSTEM AND THE PATIENT DESATURATED AND REQUIRED AN INCREASE IN SUPPLEMENTAL OXYGEN. UNTIL A NEW CSC WAS INSERTED, A REGISTERED NURSE (RN) HAD TO OCCLUDE THE SAFE SUCTION CATHETER WHERE IT WAS BROKEN WITH HER THUMB AND INCREASE THE OXYGEN. THE CSC WAS REPLACED; THERE WAS NO REPORTED INJURY. THE PATIENT WAS REPORTED TO BE STABLE ON RESPIRATORY SUPPORT.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 18169563 ↗
• InjuryNov 20, 2023Material Integrity Problem; Material Integrity Problem

  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 8030647-2023-00148 FOR THE SECOND REPORT. IT WAS REPORTED, THE CLOSED SUCTION CATHETER (CSC) HAD BEEN INSTALLED FOR ABOUT 12 HOURS WHEN IT BROKE, AT THE OBSERVATION WINDOW CLOSE TO THE SUCTION VALVE, DURING PATIENT SUCTIONING. THE BREAK CAUSED A LEAK IN THE PATIENT¿S VENTILATION SYSTEM AND THE PATIENT DESATURATED AND REQUIRED AN INCREASE IN SUPPLEMENTAL OXYGEN. UNTIL A NEW CSC WAS INSERTED, A REGISTERED NURSE (RN) HAD TO OCCLUDE THE SAFE SUCTION CATHETER WHERE IT WAS BROKEN WITH HER THUMB AND INCREASE THE OXYGEN. THE CSC WAS REPLACED; THERE WAS NO REPORTED INJURY. THE PATIENT WAS REPORTED TO BE STABLE ON RESPIRATORY SUPPORT.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 18169546 ↗
• InjuryJul 7, 2023Suction Problem; Suction Problem

  IT WAS REPORTED, THAT ON (B)(6) 023, THE SUCTION BALLARD WAS CHANGED AT THE BEGINNING OF THE SHIFT TO OBTAIN TRACHEAL ASPIRATE SAMPLE; UPON SUCTIONING WITH THE NEW BALLARD, NO SECRETIONS WERE OBTAINED. IT WAS ASSUMED THE PATIENT HAD NO SECRETIONS AND THAT THERE WAS NO ISSUE. LATER IN THE SHIFT THE PATIENT DECOMPENSATED WITH INCREASED END-TIDAL CARBON DIOXIDE (CO2) ON VENT, DECREASED VENTILATOR VOLUMES AND DECREASED OXYGEN SATURATION. SUCTION WAS AGAIN PASSED WITH NO SECRETIONS RETRIEVED; THE PATIENT STILL SOUNDED ¿COARSE¿ THE SUCTION BALLARD WAS CHANGED OUT TO A NEW ONE, AND SECRETIONS WERE ABLE TO BE REMOVED FROM THE AIRWAY. UPON PROPER SUCTIONING, THE PATIENT'S VITALS AND CO2 IMPROVED WITH INCREASE IN VENTILATOR VOLUMES AND OXYGEN SATURATION." THERE WAS NO REPORTED INJURY TO THE CHILD. THE INCIDENT OCCURRED IN THE CHILDREN¿S CARDIAC INTENSIVE CARE UNIT. MEDWATCH/ FDA USER FACILITY MW REPORT (B)(4) RECEIVED 26JUN2023 REPORTED NO NEW INFORMATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Low Oxygen Saturation

  MAUDE report 17277377 ↗
• MalfunctionJul 3, 2023Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2023-00100 FOR THE SECOND REPORT. IT WAS REPORTED, THE SHEATH SPLIT AT SEAM, CAUSING LEAK IN SYSTEM. MATERIAL APPEARS MORE ¿CRUNCHY¿ THAN NORMAL. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17252564 ↗
• InjuryJul 3, 2023Break; Gas/Air Leak; Material Integrity Problem; Break; Gas/Air Leak; Material Integrity Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2023-00099 FOR THE FIRST REPORT. IT WAS REPORTED, THAT ON (B)(6) 2023, THE PLASTIC SHEATH COVERING THE SUCTION CATHETER WAS FOUND SPLIT OPEN AT THE SEAM WHICH LEFT THE PATIENTS VENT CIRCUIT OPEN CAUSING A LEAK ON THE VENT AND THE PATIENT TO DESATURATE AND CONTAMINATED THE SUCTION CATHETER. NO INJURY REPORTED TO PATIENT.

  Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17252560 ↗
• MalfunctionMay 22, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED VIA FDA USER FACILITY REPORT MW REPORT 0533050000-2023-8004. THE FOLLOWING INFORMATION: PATIENT WAS HAVING HIS DIAPER CHANGED WITH 2 RNS. ALL OF THE SUDDEN, HEARD AIR LEAKING AND THEN VENT ALARMING. UPON INSPECTION, END OF ENDOTRACHEAL TUBE (ETT) WHERE IT CONNECTS TO THE BALLARD SUCTION ACTUALLY BROKE OFF, RNS PUSHED STAFF ASSIST, TEAM AT BEDSIDE INSTRUCTED TO PULL ETT [ENDOTRACHEAL TUBE] AND BAG, TEAM REINTUBATING PATIENT. SUCTION ADAPTER THAT INSERTS INTO ET TUBE BROKE OFF AFTER A PATIENT MOVE. THE TIP OF THE ADAPTER WAS WEDGED INSIDE OF THE ET TUBE WHICH DID NOT ALLOW FOR ANY MANUAL OR MECHANICAL VENTILATION CONNECTIVITY. DECISION WAS MADE TO PULL ET TUBE AND REINTUBATE. NO PATIENT HARM AFTER REINTUBATION. ADDITIONAL INFORMATION RECEIVED 28-APR-2023 STATING IT WAS UNKNOW HOW LONG THE CLOSED SUCTION CATHETER (CSC) WAS IN PLACE PRIOR TO THE REPORTED INCIDENT OCCURRING. THE PRODUCT WAS NOT ALTERED IN ANYWAY PRIOR TO THE REPORTED INCIDENT OCCURRING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16976463 ↗
• InjuryMay 10, 2023Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION RECEIVED 19MAY2023, FDA MEDWATCH/FDA USER FACILITY REPORT MW 16806110 RECEIVED, NO NEW INFORMATION PROVIDED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 16905997 ↗
• InjuryMay 10, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED 19MAY2023, FDA MEDWATCH / FDA USER FACILITY REPORT MW 16806110 RECEIVED, NO NEW INFORMATION PROVIDED.

  Patient problems: Bradycardia; Low Oxygen Saturation

  MAUDE report 16904360 ↗
• InjuryApr 7, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE CLOSED SUCTION CATHETER (CSC) HAD BEEN IN PLACE FOR 6-8 HOURS; THE PATIENT WAS ON POSITIVE END-EXPIRATORY PRESSURE (PEEP) 7. UPON ROUTINE VENT CHECK THE PATIENT¿S LUNG SOUNDS WERE ¿JUNKY¿ AND REQUIRED SUCTIONING; UPON ADVANCEMENT OF THE CATHETER THE CSC SLEEVE TORE AND THE PATIENT¿S OXYGEN LEVEL DECREASED TO ¿80-81%¿ AND REQUIRED MANUAL VENTILATION. THE OXYGEN LEVEL RETURNED TO 100% QUICKLY AND THERE WERE NO FURTHER COMPLICATIONS. THE CSC WAS CHANGED FOR A NEW ONE; THE PATIENT WAS REPORTED TO CURRENTLY BE IN INTENSIVE CARE UNIT (ICU) AND ¿DOING WELL'.

  Patient problems: Low Oxygen Saturation

  MAUDE report 16700692 ↗
• MalfunctionFeb 1, 2023Break; Break

  AVANOS MEDICAL 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 8030647-2023-00014 FOR THE SECOND EVENT. REFER TO 8030647-2023-00015 FOR THE THIRD EVENT. IT WAS REPORTED "A BREAK IN THE PLASTIC SHEATH COVERING [THE] INLINE BALLARD SUCTION CATHETER RESULT[ED] IN LOSS OF VENTILATOR PRESSURE TO THE INFANT." THERE WAS NO REPORTED INJURY. FDA USER FACILITY REPORT, (B)(4), RECEIVED 09-JAN-2023 STATING, "HEALTHCARE PROVIDER WAS PREPARING FOR AN ENDOTRACHEAL TUBE (ETT) SUCTION OF AN INFANT WHO HAS FREQUENT LARGE SECRETIONS. HEALTHCARE PROVIDER HAD DONNED GLOVES AND HAD BEGUN ADVANCING THE SUCTION CATHETER. AT SOME POINT AROUND 3-5 CM OF ADVANCEMENT, HEALTHCARE PROVIDER NOTICED THAT THE SUCTION CATHETER WAS EXPOSED DUE TO A LARGE SPLIT IN THE PLASTIC SHEATH COVERING. HEALTHCARE PROVIDER IMMEDIATELY WITHDREW THE CATHETER AND RESTRAINED THE INFANT FROM SELF-EXTUBATING (HIGH RISK AIRWAY) WHILE CALLING THE RESPIRATORY THERAPIST (RT) TO PROVIDE A REPLACEMENT BALLARD SUCTION CATHETER. THE NEW CATHETER SHEATH WAS NOTED TO HAVE A DIFFERENT FEEL THAN THE USUAL

  Patient problems: Decreased Peak Expiratory Flow rate

  MAUDE report 16281469 ↗
• MalfunctionFeb 1, 2023Break; Break

  AVANOS MEDICAL 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 8030647-2023-00013 FOR THE FIRST EVENT. REFER TO 8030647-2023-00014 FOR THE SECOND EVENT. IT WAS REPORTED "A BREAK IN THE PLASTIC SHEATH COVERING [THE] INLINE BALLARD SUCTION CATHETER RESULT[ED] IN LOSS OF VENTILATOR PRESSURE TO THE INFANT." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 17-JAN-2023 STATED THE CATHETER FAILED AS THE CLINICIANS WERE ATTACHING IT TO THE RESPIRATORY CIRCUIT. THE "INFANT WAS RECEIVING RESPIRATORY SUPPORT: SERVOU [BRAND OF MECHANICAL VENTILATOR] ETT (ENDOTRACHEAL TUBE) CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) WITH PRESSURE SUPPORT BREATHS. BACK UP RATE OF 30 WITH 10 SEC DELAY, BUR (BACK-UP RATE) 30, PEEP 7, PS OF 12 (HITTING PIPS [PEAK AIRWAY PRESSURE'S] OF 19-20) FIO2 (FRACTION OF INSPIRED OXYGEN), 21. WHEN CATHETER FAILED, IT WAS IMMEDIATELY REMOVED FROM THE CIRCUIT RESTORING PRESSURES. BRIEF INCREASE IN FIO2 NO OTHER DECOMPENSATION. NO HARM TO INFANT. INFANT REMAINS STABLE, INTUBATED IN THE NICU (NEONATAL INTENSIVE CARE UNIT).

  Patient problems: Decreased Peak Expiratory Flow rate

  MAUDE report 16280494 ↗
• MalfunctionFeb 1, 2023Break; Break

  AVANOS MEDICAL 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 8030647-2023-00013 FOR THE FIRST EVENT. REFER TO 8030647-2023-00015 FOR THE THIRD EVENT. IT WAS REPORTED "A BREAK IN THE PLASTIC SHEATH COVERING [THE] INLINE BALLARD SUCTION CATHETER RESULT[ED] IN LOSS OF VENTILATOR PRESSURE TO THE INFANT." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 17-JAN-2023 STATED THE CATHETER FAILED ON THE SAME PATIENT WITHIN 24-HOURS. THE "INFANT WAS RECEIVING RESPIRATORY SUPPORT: SERVOU [BRAND OF MECHANICAL VENTILATOR] ETT (ENDOTRACHEAL TUBE) CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) WITH PRESSURE SUPPORT BREATHS. BACK UP RATE OF 30 WITH 10 SEC DELAY, BUR (BACK-UP RATE) 30, PEEP 7, PS OF 12 (HITTING PIPS [PEAK AIRWAY PRESSURE'S] OF 19-20) FIO2 (FRACTION OF INSPIRED OXYGEN), 21. WHEN CATHETER FAILED, IT WAS IMMEDIATELY REMOVED FROM THE CIRCUIT RESTORING PRESSURES. BRIEF INCREASE IN FIO2 NO OTHER DECOMPENSATION. NO HARM TO INFANT. INFANT REMAINS STABLE, INTUBATED IN THE NICU (NEONATAL INTENSIVE CARE UNIT).

  Patient problems: Decreased Peak Expiratory Flow rate

  MAUDE report 16280492 ↗
• MalfunctionDec 27, 2022Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER WOULD NOT SUCTION. NO INJURY OR MEDICAL INTERVENTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 2022-12-12, 'THE ISSUE HAD BEEN RESOLVED AND THE MEDICAL DEVICE INCIDENT IS NO LONGER NECESSARY. THIS FILE CAN BE CLOSED.' NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16056689 ↗
• MalfunctionNov 21, 2022Break; Break

  IT WAS REPORTED THE Y-ADAPTOR PIECE BROKE INTO TWO PIECES WHILE ON A PATIENT CAUSING A SAFETY ISSUE THAT AFFECTED THE PATIENT. THE DEVICE HAD BEEN IN PLACE SINCE (B)(6) 2022 AT 1750. MEDICAL INTERVENTIONS REQUIRED INCLUDED "INCREASE VENTILATOR SETTINGS, INCLUDING FIO2 AND A NEW 'WYE' HAD TO BE PLACED ON THE PATIENT ETT [ENDOTRACHEAL TUBE] FOR THE CSC [CLOSED SUCTION CATHETER]. THE PATIENT IS REPORTED TO BE STABLE.

  Patient problems: Pulmonary Valve Insufficiency/ Regurgitation

  MAUDE report 15835266 ↗
• MalfunctionAug 2, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2022-00165 FOR THE FIRST REPORT. IT WAS REPORTED THAT DURING SETUP OF THE CLOSED SUCTION CATHETER (CSC), THE DEVICE WAS FOUND TO BE ON CONSTANT VACUUM REGARDLESS OF THUMB CONTROL SUCTION BUTTON POSITION. THE CATHETER WAS REMOVED FROM USE AND A NEW WORKING DEVICE WAS ADDED TO THE PATIENT'S VENTILATOR CIRCUIT. THE PATIENT TOLERATED THE PROCEDURE WELL, WITH NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15150536 ↗
• MalfunctionJul 6, 2022Suction Failure; Suction Failure

  IT WAS REPORTED THAT DURING SETUP OF THE CLOSED SUCTION CATHETER (CSC), THE DEVICE WAS FOUND TO BE ON CONSTANT VACUUM REGARDLESS OF THUMB CONTROL SUCTION BUTTON POSITION. THE CATHETER WAS REMOVED FROM USE AND A NEW WORKING DEVICE WAS ADDED TO THE PATIENT'S VENTILATOR CIRCUIT. THE PATIENT TOLERATED THE PROCEDURE WELL, WITH NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14929775 ↗
• MalfunctionJun 19, 2022Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER (CSC) DID NOT APPEAR TO HAVE ANY SUCTION, THE CSC WAS REPLACED; THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14741326 ↗
• MalfunctionMay 23, 2022Suction Failure; Suction Failure

  IT WAS REPORTED THAT WHEN IN USE, ON THE PATIENT, THE CATHETER DID NOT SUCTION AND FLOODED THE PATIENT WITH STERILE WATER. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 02MAY2022 REPORTED THERE WERE NO ILL EFFECTS AS A RESULT OF THE REPORTED INCIDENT; THE CLOSED SUCTION CATHETER (CSC) WAS REPLACED FOR A NEW ONE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14476604 ↗
• MalfunctionMay 11, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 8030647-2022-00133 FOR THE FIRST EVENT. REFER TO 8030647-2022-00144 FOR THE THIRD EVENT. REFER TO 8030647-2022-00145 FOR THE FOURTH EVENT. REFER TO 8030647-2022-00146 FOR THE FIFTH EVENT. IT WAS REPORTED, WHEN USED TO SUCTION THE PATIENT, THE CATHETER MALFUNCTIONED AND DIDN'T ASPIRATE ANYTHING. THE CATHETER WAS REPLACED FOR A NEW DEVICE. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 21-APR-2022 STATING THE DEVICE WAS EXCHANGED FOR A FUNCTIONING CATHETER. THE PATIENT'S CURRENT HEALTH STATUS NOT AFFECTED BY THIS PRODUCT AND THE PATIENT WAS NOT RE-INTUBATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366708 ↗
• MalfunctionMay 11, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 8030647-2022-00133 FOR THE FIRST EVENT. REFER TO 8030647-2022-00134 FOR THE SECOND EVENT. REFER TO 8030647-2022-00145 FOR THE FOURTH EVENT. REFER TO 8030647-2022-00146 FOR THE FIFTH EVENT. IT WAS REPORTED, WHEN USED TO SUCTION THE PATIENT, THE CATHETER MALFUNCTIONED AND DIDN'T ASPIRATE ANYTHING. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14366700 ↗