Ballard* Closed Suction System 93824Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00609038938240), received between Jan 21, 2022 and Sep 29, 2026 — classified as 11 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50940511 ↗
• MalfunctionSep 29, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50940510 ↗
• MalfunctionMar 6, 2025Break; Break

  IT WAS REPORTED, THE BALLARD IN-LINE SUCTION SNAPPED OFF WITH THE SPIKE BEING STUCK IN THE OPENING OF THE 3.0 ENDOTRACHEAL TUBE (ETT), THIS MADE IT IMPOSSIBLE TO BAG THE PATIENT. THE RESPIRATORY THERAPIST (RT) CUT THE ETT AND INSERT A NEW BALLARD IN ORDER TO BAG THE PATIENT; THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21540215 ↗
• InjuryJan 3, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2025-00002 FOR THE FIRST REPORT IT WAS REPORTED, A NEW 6FRENCH ENDOTRACHEAL TUBE (ETT) BALLARD WAS PLACED; HOWEVER, WHEN AN ATTEMPT TO SUCTION THE NEONATE WAS MADE THE CATHETER KEPT POPPING OFF OF THE Y PIECE (WOULD NOT PASS THE Y INTERFACE), WHICH RESULTED IN CIRCUIT PRESSURE LOSS IN THE VENTILATOR CIRCUIT. THE FELLOW RESPIRATORY THERAPIST (RT) REPLACED THE Y PIECE FROM A 5F ETT BALLARD PACKAGE AND ATTEMPTED TO PUSH THE 6 FRENCH CATHETER INTO THE NEW Y PIECE, THIS FIXED THE Y PIECE OBSTRUCTION; HOWEVER, THE 6F BALLARD CONTINUED TO POP OUT OF THE Y PIECE WHICH LEAD TO PRESSURE LOSS. THE RT PLACED THE 5 FRENCH CATHETER AND IT PASSED WITH SUCCESS; THE BABY WAS SUCTIONED ORALLY VIA THE ETT; THE NEONATES HEARTRATE AND SATURATIONS RETURNED TO BASELINE AND THEIR VITALS WENT DOWN FOR 2 MINUTES.

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

  MAUDE report 21067908 ↗
• InjuryJan 3, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2025-00003 FOR THE SECOND REPORT IT WAS REPORTED, AN ATTEMPT TO REPOSITION THE NEONATE ON THE OSCILLATOR VENT WAS MADE; THE BABY RECEIVED SLIGHT CONDENSATION THROUGH THE ENDOTRACHEAL TUBE (ETT) AND THEIR HEART RATE AND OXYGEN SATURATIONS BEGAN TO DROP. AN ATTEMPT TO SUCTION THE NEONATE WITH THE CURRENT 6FRENCH ETT SUCTION AND THE BALLARD WAS MADE; HOWEVER, THE CATHETER KEPT POPPING OFF OF THE Y PIECE (WOULD NOT PASS THE Y INTERFACE), WHICH RESULTED IN CIRCUIT PRESSURE LOSS. AN UNSUCCESSFUL ATTEMPT TO TWIST THE CATHETER INTERNALLY WAS PERFORMED; THE CATHETER WAS REPLACED.

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

  MAUDE report 21067907 ↗
• MalfunctionSep 11, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED, [THE] SUCTION HAD "DEAD SPACE" AND WATER ACCUMULATION, THE ADAPTER WAS TOO SKINNY FOR [THE] SUCTION TUBING AND THEY HAD TO CUT IT OFF/MODIFY IT TO MAKE IT WORK. THE BABY WAS DISCONNECTED AND TURNED [IN ORDER TO] PREVENT ASPIRATION AND THE WATER WAS REMOVED. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20191482 ↗
• InjuryFeb 28, 2024Material Integrity Problem; Material Integrity Problem

  FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT MW5150576 REPORTED, "APPROXIMATELY 4CM OF THE 6 FRENCH AVANOS INLINE SUCTION CATHETER TIP WAS DISCOVERED TO BE A RETAINED FOREIGN OBJECT WITHIN THE LUNG OF AN INTUBATED NEONATE PATIENT. IT IS UNKNOWN AS TO WHETHER OR NOT THE CATHETER TIP WAS INADVERTENTLY SEVERED OR IF THE CATHETER TORE DURING USE¿¿ IT WAS NOT REPORTED IF ANY MEDICAL INTERVENTION WAS PROVIDED; THE PATIENT¿S CURRENT CONDITION IS UNKNOWN. FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT MW5150575 DID NOT PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18797386 ↗
• InjuryNov 20, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, A ¿VENTILATED PATIENT [DESATURED] AND [BECAME BRADYCARDIC AND] DID NOT RESPOND TO ADMINISTERED OXYGEN SUPPLEMENT.¿ THE DECISION WAS MADE TO SUCTION THE CHILD'S TRACHEA. IT WAS NOTED THAT THE RESPIRATORY THERAPIST AND NURSE OBSERVED THAT 14CM OF THE PROTECTIVE SHEATH WAS ¿BROKEN¿ AND THE CATHETER WAS EXPOSED TO AMBIENT AIR; PROPER PLACEMENT OF THE TUBE WAS CONFIRMED. ADDITIONAL INFORMATION RECEIVED 08NOV2023 REPORTED, THE CHILD WAS ON A VENTILATOR WHEN THE DESATURATION AND BRADYCARDIA OCCURRED. THE PATIENT¿S CURRENT CONDITION WAS NOT REPORTED.

  Patient problems: Arrhythmia; Low Oxygen Saturation

  MAUDE report 18179037 ↗
• MalfunctionJun 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THE PATIENT WAS DECOMPENSATING, IT WAS UNCLEAR IF THE PATIENT STATUS WAS RELATED TO AN EQUIPMENT FAILURE. THE REGISTERED NURSE (RN) DISCOVERED THE CLOSED SUCTION CATHETER OVERWRAP WAS TORN BEFORE ATTEMPTING TO SUCTION THE PATIENT AND STOPPED, THE RESPIRATORY THERAPIST (RT) REPLACED THE EQUIPMENT. THE PRODUCT HAD BEEN IN USE FOR "SEVERAL DAYS" PRIOR TO THE INCIDENT, THE PATIENT RECOVERED AND IS "CURRENTLY STABLE".

  Patient problems: Respiratory Insufficiency

  MAUDE report 17127216 ↗
• MalfunctionJun 1, 2023Migration or Expulsion of Device; Device Markings/Labelling Problem; Migration or Expulsion of Device; Device Markings/Labelling Problem

  IT WAS REPORTED "CLOSED SYSTEM INLINE SUCTION CATHETER MARKINGS ARE NOT ALIGNING WITH THE ETT (ENDOTRACHEAL TUBE) MARKINGS CAUSING THE SUCTION CATHETER TO GO BEYOND THE ETT." A PATIENT EXPERIENCED AND UNPLANNED EXTUBATION IN WHICH THE PATIENT HAD A COUGHING INCIDENT AFTER SUCTIONING WHICH DISLODGED THE ETT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17043504 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AVANOS BALLARD CLOSED SUCTION 6 FRENCH PLASTIC SHEATH DOES NOT ALLOW ADVANCING OF SUCTION CATHETER IN A TIMELY MANNER AND CHILD DESATURATED AND BRADS. PATIENT REQUIRED 100% OXYGEN. PER ADDITIONAL INFORMATION RECEIVED ON 12MAY2023, THERE WAS NO LONG-TERM IMPACT AND THE PATIENT HAS SINCE RECOVERED.

  Patient problems: Bradycardia; Low Oxygen Saturation

  MAUDE report 16996134 ↗
• MalfunctionMar 30, 2023Malposition of Device; Malposition of Device

  FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT (B)(4) REPORTED, THE INTUBATED INFANT WAS FOUND WITH THE SUCTION CATHETER THREADED BEYOND THE ¿Y¿ OF CIRCUIT, CREATING A BARRIER TO THE INFANT'S AIR FLOW. THE LAST SUCTION WAS IN THE EVENING WITH PATIENT CARE; [THE ISSUE WAS] NOTICED APPROXIMATELY 2.5 HOURS LATER WHEN THE [REGISTERED NURSE] RN WENT TO DRAW LABS. IT WAS REPORTED THAT IT SEEM[ED] POSSIBLE THE CATHETER WAS NOT PULLED BACK ALL THE WAY. AN ADDITIONAL BLOOD GAS WAS DRAWN 30 MINUTES FOLLOWING DUE TO THE CONCERN FOR INCREASED PCO2 BEING CAUSED BY DISRUPTION OF SUCTION CATHETER IN [ENDOTRACHEAL TUBE] ETT. NO OTHER KNOWN HARM WAS CAUSED. ADDITIONAL INFORMATION RECEIVED 16MAR2023 REPORTED THE INFANT¿S BLOOD GAS LEVELS ON THE DAY OF THE EVENT, WHICH OCCURRED AT APPROXIMATELY 1100. 0523-C02 61.8, 1119-C02 67.2, 1207- C02 67.6. THE PATIENT¿S CURRENT STATUS WAS UNKNOWN; NO OTHER HARM WAS REPORTED.

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

  MAUDE report 16645837 ↗
• MalfunctionMar 17, 2023Break; Break

  IT WAS REPORTED THE "SUCTION BALLARD BROKEN AT DISTAL END WHILE SUCTIONING PATIENT. DISTAL END BROKE AND BECAME DISLODGED FROM Y CONNECTOR SITE WITH PLASTIC PIECE AT END OF BALLARD DISCONNECTED FROM SHEATH. A SPARE SUCTION BALLARD WAS AT THE PATIENTS BEDSIDE AT TIME OF THE INCIDENT AND WAS REPLACED IMMEDIATELY." THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16565031 ↗
• InjuryFeb 14, 2023Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2023-00019 FOR THE FIRST EVENT. IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER SLEEVE WAS FOUND TORN AND THE CATHETER WAS EXPOSED. THE CLINICIANS WERE UNABLE TO DETERMINE HOW LONG THE PATIENT HAD BEEN SUCTIONED WITH UNSTERILE CATHETER. THE DEVICE WAS IMMEDIATELY REPLACED, AND STERILE TRACHEAL ASPIRATE WAS OBTAINED AND SENT. A SEPTIC WORKUP HAD BEEN DRAWN HOURS EARLIER DUE TO INSTABILITY AND LABILITY IN OXYGEN REQUIREMENT AND SAO2 (OXYGEN SATURATION) PRE/POST SPLIT. THE PATIENT HAD INCREASED LABILITY SIGNS OF INFECTION THE PREVIOUS 12-HOURS. TRACHEAL ASPIRATE WAS OBTAINED AND MSSA (METICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS) TRACHEITIS REQUIRING 7-DAYS OF ANTIBIOTICS TREATMENT.

  Patient problems: Bacterial Infection; Low Oxygen Saturation

  MAUDE report 16376062 ↗
• InjuryFeb 14, 2023Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2023-00020 FOR THE SECOND EVENT. IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER SLEEVE WAS FOUND TORN AND THE CATHETER WAS EXPOSED. IT'S UNKNOWN HOW LONG THE SLEEVE WAS TORN. TWO DAYS LATER, THE PATIENT HAD A POSITIVE TRACHEAL ASPIRATE FOR MSSA (METICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS) AND A BLOODSTREAM INFECTION OF THE SAME ORGANISM. PATIENT HAD SIGNIFICANT DECOMPENSATION WITH THIS INFECTION, REQUIRED ANTIBIOTICS, AND INCREASED ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) AND VASOPRESSOR SUPPORT. THE PATIENT DEVELOPED SIGNS OF BEING PROTHROMBOTIC AND HAD INCREASED INFLAMMATORY MARKERS. THIS RESULTED IN AN URGENT ECMO CIRCUIT CHANGE TWO TIMES. DURING ONE EVENT THE PATIENT SUFFERED A NEAR ARREST REQUIRING RESUSCITATION. ULTIMATELY THE PATIENT SHOWED NEUROLOGIC INJURY AND SUPPORT WAS WITHDRAWN. THIS DID NOT GET COUNTED AS A CLABSI (CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION) DUE TO BEING ON ECMO BUT WAS COUNTED AS A BSI (BLOODSTREAM INFECTION). ADDITIONAL INFORMATION RECEIV

  Patient problems: Bacterial Infection; Brain Injury; Cardiac Arrest; Low Oxygen Saturation

  MAUDE report 16376056 ↗
• MalfunctionJul 1, 2022Suction Failure; Suction Failure

  ON 06-JUN-2022 ADDITIONAL INFORMATION WAS RECEIVED STATING "WHEN SUCTION SYSTEM IS CONNECTED TO SUCTION IN THE WALL THE OUTER CLEAR SLEEVE WOULD FILL WITH AIR." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14893778 ↗
• MalfunctionApr 20, 2022Suction Problem; Suction Problem

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW (B)(4).THE FOLLOWING: BALLARD SUCTIONING DEVICE FOR ENDOTRACHEAL TUBE (ETT) SUCTION, WOULD NOT FUNCTION; THE TUBE WAS REPLACED AND THE ISSUE RESOLVED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14161791 ↗
• MalfunctionFeb 28, 2022Suction Problem; Suction Problem

  IT WAS REPORTED THE "BALLARD CATHETER WAS FOUND TO BE DEFECTIVE ON A PATIENT." THERE WAS NO REPORTED INJURY. THE SUCTION THUMB KNOB WOULD NOT COME BACK TO THE NORMAL POSITION AFTER DEPRESSING FOR SUCTION. ADDITIONAL INFORMATION RECEIVED 02-FEB-2022 STATED THE DEVICE WAS IN USE FOR 5-DAYS PRIOR TO THE REPORTED INCIDENT OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13621951 ↗
• InjuryFeb 3, 2022Suction Failure; Suction Failure

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT (B)(4). THE FOLLOWING INFORMATION: TRACHEAL ASPIRATE BEING OBTAINED BY PROPER PROCEDURE AND UPON ATTEMPT TO SUCTION AND CLEAR THE BALLARD CLOSED SUCTION CATHETER (WITH NORMAL SALINE), IT WAS NOTICED THAT SUCTION (VERIFIED TO BE ON AND FUNCTIONING) WAS NOT REACHING THE PATIENT'S AIRWAY THROUGH THE CATHETER. SUCTION TUBING, CATHETER AND MUCOUS COLLECTION SPECIMEN CONTAINER WERE TROUBLESHOOTED FOR LEAKS. ATTEMPTED TO SUCTION PATIENT'S AIRWAY AGAIN WITHOUT SUCCESS. AGAIN, NOTED BY FEEL AND HEARING, THE END OF THE SUCTION TUBING HAS SUCTION PRESENT, BUT THE SUCTION WAS NOT ACTUALLY REACHING THE CATHETER TIP WHILE DEPRESSING THE THUMB BUTTON. BALLARD WAS REMOVED AND A 6FR OPEN SUCTION WAS USED TO CLEAR BOTH THE SECRETIONS AND NORMAL SALINE THAT HAS BEEN INADVERTENTLY INSTILLED INTO THE PATIENT'S AIRWAY. PATIENT VITALS DECOMPENSATED-REQUIRED FIO2 FOR A SHORT PERIOD. A NEW BALLARD WAS USED TO OBTAIN AN ASPIRATE AND CONTINUED CLEARANCE OF THE AIRWAY. ADDITIONAL INFORMATION RECEIVED 18-JAN-2022 STATED THE "BALLARD MALFUNCTION RESULTED IN PATIENT DECOMPENSATION WITH NEED TO REMOVE BALLARD AND SUCTION AIRWAY MANUALLY."

  Patient problems: Low Oxygen Saturation; Unspecified Respiratory Problem

  MAUDE report 13446412 ↗
• MalfunctionJan 28, 2022Break; Break

  IT WAS REPORTED THE "PATIENT WAS ORIGINALLY REPOSITIONED TO FACE THE LEFT SIDE OF THE ISOLETTE, BUT WASN'T TOLERATING THAT POSITION. SO THE PATIENT WAS REPOSITIONED TO FACE THE RIGHT SIDE OF THE ISOLETTE. DURING THE CARE TIME, THE TUBE WAS APPROPRIATELY AT 5.5CM AT THE LIP. THE VITALS WERE WITHIN NORMAL LIMITS. THE BEDSIDE RN [REGISTERED NURSE] GOT AN ABG [ARTERIAL BLOOD GASES] AT 1100AM. THE RT [RESPIRATORY THERAPIST] CALLED THE RESULTS TO THE PA [PHYSICIAN'S ASSISTANT]. THE RESULTS WERE THOUGHT TO BE INACCURATE, SO THE ABG WAS REDRAWN. THE RESULTS CAME BACK ALMOST LIKE THE PREVIOUS RESULTS." IT WAS NOTED "THE LAVAGE PORT FROM THE SUCTION CATHETER HAD FALLEN OFF THE INLINE SUCTION LINE." THIS CAUSED A LEAK IN THE VENTILATOR CIRCUIT. OCCASIONALLY THE LOW VE [LOW MINUTE VENTILATION] ALARM WOULD GO OFF, BUT NOT CONSTANTLY. THE RESPIRATORY THERAPIST REPLACED IN INLINE SUCTION CATHETER AND REPLACED THE FLOW SENSOR BECAUSE IT WAS "SOILED." THE VENTILATOR GRAPHICS AND THE PARAMETERS WERE WITHIN NORMAL LIMITS. AN ABG WOULD BE REDRAWN. THE PATIENT WAS ALREADY IN CRITICAL CONDITION AND CONTINUED TO BE IN CRITICAL CONDITION.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 13386237 ↗
• InjuryJan 25, 2022Suction Failure; Suction Failure

  IT WAS REPORTED THAT DURING A TRACHEAL ASPIRATION PROCEDURE THE CLOSED SUCTION CATHETER (CSC) WOULD NOT SUCTION SECRETIONS. A 6FRENCH OPEN SUCTION CATHETER ALONG WITH NORMAL SALINE WAS USED TO CLEAR THE SECRETIONS FROM THE PATIENT'S AIRWAY. THE PATIENT'S VITAL SIGNS DECOMPENSATED AND THE PATIENT'S FRACTION OF INSPIRED OXYGEN (FIO2) SETTING HAD TO BE INCREASED FOR A SHORT WHILE; THERE WAS NO REPORT OF INJURY.

  Patient problems: Low Oxygen Saturation; Unspecified Respiratory Problem

  MAUDE report 13347002 ↗
• MalfunctionJan 24, 2022Difficult to Open or Close; Difficult to Open or Close

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2022-00003 FOR THE FIRST EVENT. IMMEDIATELY AFTER INSTALLING THE DEVICE SALINE BEGAN GOING INTO MY PATIENT'S LUNGS INSTEAD OF THE SUCTION SYSTEM. THE PATIENT BEGAN TO DECOMPENSATE AND THE OXYGEN LEVEL DESATURATED. THE DEVICE WAS REPLACED AND THE PATIENT WAS QUICKLY SUCTIONED. ADDITIONAL INFORMATION RECEIVED 31-DEC-2021 VIA FDA MEDWATCH/ FDA USER FACILITY REPORT # (B)(4) STATED: DESCRIBE THE EVENT OR PROBLEM: RESPIRATORY THERAPIST (RT) WENT IN TO DO CARE ON MY MICRO PREEMIE PATIENT IN THE NEST BED. PATIENT WAS UNSTABLE ALL DAY, ON THE VENT WITH INO (NITRIC OXIDE), PATIENT SPO2 KEPT ON DROPPING, SO WE DECIDED TO GO IN TO REPOSITION AND SUCTION. AFTER ASSESSING PATIENT'S LUNG SOUNDS BILATERALLY, RT PROCEED TO ADVANCE THE SUCTION CATHETER WITH LOT NUMBER 30142957, REF 196, INTO THE ETT (ENDOTRACHEAL TUBE) TO SUCTION PATIENT. AFTER RETRACTING THE CATHETER, RT INSTILLED 1 ML OF SALINE INTO THE CATHETER TO CLEAR IT. NO VISIBLE SECRETIONS CAME THROUGH, SO RT INSTILLED 1 MORE ML

  Patient problems: Low Oxygen Saturation; Respiratory Insufficiency

  MAUDE report 13335055 ↗
• InjuryJan 24, 2022Difficult to Open or Close; Difficult to Open or Close

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2022-00004 FOR THE SECOND EVENT. IMMEDIATELY AFTER INSTALLING THE DEVICE SALINE BEGAN GOING INTO MY PATIENT'S LUNGS INSTEAD OF THE SUCTION SYSTEM. THE PATIENT BEGAN TO DECOMPENSATE AND THE OXYGEN LEVEL DESATURATED. THE DEVICE WAS REPLACED AND THE PATIENT WAS QUICKLY SUCTIONED.

  Patient problems: Low Oxygen Saturation; Respiratory Insufficiency

  MAUDE report 13335048 ↗
• InjuryJan 21, 2022Break; Break

  IT WAS REPORTED VIA FDA MEDWATCH MW12180155 THE FOLLOWING INFORMATION: A FRAGMENT FROM AN INLINE SUCTION CATHETER WAS FOUND IN THE LEFT BRONCHUS OF A (B)(6)PATIENT SEVERAL DAYS AFTER INITIAL INTUBATION. SURGICAL INTERVENTION WAS NEEDED TO REMOVE THE FOREIGN OBJECT CONFIRMED TO BE A FRAGMENT FROM A KIMBERLY CLARK KIMVENT CLOSED SUCTION SYSTEM FOR NEONATAL/ PEDIATRIC, 6 FR "Y" ENDOTRACHEAL TUBE ADAPTER. 1800 CXR CHEST X-RAY SHOWED POSSIBLE FOREIGN OBJECT, LINEAR 1.7CM LENGTH, 3MM DIAMETER. IMAGING HISTORY REVIEWED BY MD AND BEDSIDE NURSE. OBJECT WAS APPRECIATED ON PREVIOUS CXR, BUT WAS DIFFICULT TO SEE AND WAS NOT IDENTIFIED ON RADIOLOGY REPORT. PREVIOUS X-RAYS DID NOT SHOW ANYTHING THAT COULD BE IDENTIFIED AS A FOREIGN OBJECT. INFANT'S BED WAS CHECKED FOR EXTERNAL OBJECT AND NEW IMAGING WAS OBTAINED TO CONFIRM OBJECT WAS INDEED INSIDE OF THE PATIENT'S LUNG FIELD. WHEN CONFIRMED THAT OBJECT WAS NOT EXTERNAL, (B)(6) WAS CONSULTED AND THE DECISION WAS MADE TO TRANSPORT INFANT FOR FURTHER EVALUATION AND INTERVENTION DUE TO THE AVAILABILITY OF A TRANSPORT VENTILATOR THAT IS AVAILABLE AT PCMC. FOLLOW UP AT PCMC AND RETRIEVAL OF THE FOREIGN BODY CONFIRMED THAT IT WAS A 6FR SUCTION TRACHCAR

  Patient problems: Foreign Body In Patient

  MAUDE report 13315112 ↗