Ballard* Closed Suction System 92431Recalls & reported problems

Summary

The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 00609038924311), received between Feb 2, 2022 and Oct 30, 2025 — classified as 21 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (27 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 78 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Material Puncture/Hole; Material Puncture/Hole

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 8030647-2025-00114 FOR THE FIRST REPORT. REFER TO 8030647-2025-00115 FOR THE SECOND REPORT. REFER TO 8030647-2025-00117 FOR THE FOURTH REPORT. IT WAS REPORTED: THE DEVICE HAD A HOLE IN AN UNSPECIFIED LOCATION; DISCOVERED DURING USE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430825 ↗
• MalfunctionOct 30, 2025Material Puncture/Hole; Material Puncture/Hole

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 8030647-2025-00115 FOR THE SECOND REPORT. REFER TO 8030647-2025-00116 FOR THE THIRD REPORT. REFER TO 8030647-2025-00117 FOR THE FOURTH REPORT. IT WAS REPORTED: THE DEVICE HAD A HOLE IN AN UNSPECIFIED LOCATION; DISCOVERED DURING USE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430824 ↗
• MalfunctionOct 30, 2025Material Puncture/Hole; Material Puncture/Hole

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 8030647-2025-00114 FOR THE FIRST REPORT. REFER TO 8030647-2025-00115 FOR THE SECOND REPORT. REFER TO 8030647-2025-00116 FOR THE THIRD REPORT. IT WAS REPORTED: THE DEVICE HAD A HOLE IN AN UNSPECIFIED LOCATION; DISCOVERED DURING USE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430823 ↗
• MalfunctionOct 30, 2025Material Puncture/Hole; Material Puncture/Hole

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 8030647-2025-00114 FOR THE FIRST REPORT. REFER TO 8030647-2025-00116 FOR THE THIRD REPORT. REFER TO 8030647-2025-00117 FOR THE FOURTH REPORT. IT WAS REPORTED: THE DEVICE HAD A HOLE IN AN UNSPECIFIED LOCATION; DISCOVERED DURING USE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430822 ↗
• MalfunctionOct 7, 2025Break; Break

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030647-2025-00094 FOR THE SECOND REPORT. REFER TO 8030647-2025-00095 FOR THE THIRD REPORT. IT WAS REPORTED: THE PLASTIC SHEATH BROKE DURING SUCTIONING ON THE PATIENT END OF THE CATHETER. THE CATHETER WAS CHANGED; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23232833 ↗
• MalfunctionOct 7, 2025Break; Break

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 8030647-2025-00093 FOR THE FIRST REPORT. REFER TO 8030647-2025-00095 FOR THE THIRD REPORT. IT WAS REPORTED: THE PLASTIC SHEATH BROKE DURING SUCTIONING ON THE PATIENT END OF THE CATHETER. THE CATHETER WAS CHANGED; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23232832 ↗
• MalfunctionOct 7, 2025Break; Break

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030647-2025-00093 FOR THE FIRST REPORT. REFER TO 8030647-2025-00094 FOR THE SECOND REPORT. IT WAS REPORTED: THE PLASTIC SHEATH BROKE DURING SUCTIONING ON THE PATIENT END OF THE CATHETER. THE CATHETER WAS CHANGED; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23232831 ↗
• InjuryJun 10, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  FDA MW REPORT MW5169668 REPORTED, PATIENT USES THE BALLARD 8 FR SUCTION CATHETERS, WHICH WERE RECENTLY RECALLED FOR BEING NON-STERILE. IN THE LAST WEEK, PATIENT EXPERIENCED SYMPTOMS OF PNEUMONIA. CAREGIVERS BELIEVE THIS COULD HAVE BEEN CAUSED BY THE USE OF THE NON-STERILE SUCTION CATHETERS. THE SYMPTOMS HAVE SINCE SUBSIDED. UPON FURTHER INVESTIGATION, THE PATIENT HAD THE RECALLED PRODUCT IN THE HOME.

  Patient problems: Pneumonia

  MAUDE report 22176120 ↗
• MalfunctionJan 16, 2025Break; Break

  IT WAS REPORTED, THE CARE-PROVIDER HAD TO 'FISH OUT' THE PIECE THAT BROKE INSIDE THE PATIENT'S AIRWAY- TRACHEA WITH A PLASTIC CLAMP- TWEEZER. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173222 ↗
• MalfunctionApr 30, 2024Decrease in Suction; Excess Flow or Over-Infusion; Unintended Deflation; Decrease in Suction; Excess Flow or Over-Infusion; Unintended Deflation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TEN REPORTS. REFER TO 8030647-2024-00026 FOR THE FIRST REPORT, REFER TO 8030647-2024-00028 FOR THE THIRD REPORT, REFER TO 8030647-2024-00029 FOR THE FOURTH REPORT, REFER TO 8030647-2024-00030 FOR THE FIFTH REPORT, REFER TO 8030647-2024-00031 FOR THE SIXTH REPORT, REFER TO 8030647-2024-00032 FOR THE SEVENTH REPORT, REFER TO 8030647-2024-00033 FOR THE EIGHTH REPORT, REFER TO 8030647-2024-00034 FOR THE NINTH REPORT, REFER TO 8030647-2024-00035 FOR THE TENTH REPORT. THE PARENT OF THE PATIENT REPORTED, THE AREA AROUND THE INLINE SUCTION CATHETER(S) WERE FILLING UP WITH AIR AND THEN COMPLETELY DEFLATED. THE CATHETER(S) WERE NOT EASILY REMOVED FROM THE PATIENT¿S TRACH AND THE PATIENT WAS NO ABLE TO BE SUCTIONED EFFECTIVELY. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 10APR2024 REPORTED, THERE WAS NO HARM TO THE PATIENT.

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

  MAUDE report 19212694 ↗
• MalfunctionApr 30, 2024Decrease in Suction; Excess Flow or Over-Infusion; Unintended Deflation; Decrease in Suction; Excess Flow or Over-Infusion; Unintended Deflation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TEN REPORTS. REFER TO 8030647-2024-00027 FOR THE SECOND REPORT ; REFER TO 8030647-2024-00028 FOR THE THIRD REPORT; REFER TO 8030647-2024-00029 FOR THE FOURTH REPORT; REFER TO 8030647-2024-00030 FOR THE FIFTH REPORT; REFER TO 8030647-2024-00031 FOR THE SIXTH REPORT; REFER TO 8030647-2024-00032 FOR THE SEVENTH REPORT; REFER TO 8030647-2024-00033 FOR THE EIGHTH REPORT; REFER TO 8030647-2024-00034 FOR THE NINTH REPORT; REFER TO 8030647-2024-00035 FOR THE TENTH REPORT. THE PARENT OF THE PATIENT REPORTED, THE AREA AROUND THE INLINE SUCTION CATHETER(S) WERE FILLING UP WITH AIR AND THEN COMPLETELY DEFLATED. THE CATHETER(S) WERE NOT EASILY REMOVED FROM THE PATIENT¿S TRACH AND THE PATIENT WAS NO ABLE TO BE SUCTIONED EFFECTIVELY. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 10APR2024 REPORTED, THERE WAS NO HARM TO THE PATIENT.

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

  MAUDE report 19212549 ↗
• MalfunctionApr 30, 2024Decrease in Suction; Excess Flow or Over-Infusion; Unintended Deflation; Decrease in Suction; Excess Flow or Over-Infusion; Unintended Deflation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIFTH OF TEN REPORTS. REFER TO 8030647-2024-00026 FOR THE FIRST REPORT; REFER TO 8030647-2024-00027 FOR THE SECOND REPORT; REFER TO 8030647-2024-00028 FOR THE THIRD REPORT ; REFER TO 8030647-2024-00029 FOR THE FOURTH REPORT; REFER TO 8030647-2024-00031 FOR THE SIXTH REPORT; REFER TO 8030647-2024-00032 FOR THE SEVENTH REPORT; REFER TO 8030647-2024-00033 FOR THE EIGHTH REPORT; REFER TO 8030647-2024-00034 FOR THE NINTH REPORT; REFER TO 8030647-2024-00035 FOR THE TENTH REPORT. THE PARENT OF THE PATIENT REPORTED, THE AREA AROUND THE INLINE SUCTION CATHETER(S) WERE FILLING UP WITH AIR AND THEN COMPLETELY DEFLATED. THE CATHETER(S) WERE NOT EASILY REMOVED FROM THE PATIENT¿S TRACH AND THE PATIENT WAS NO ABLE TO BE SUCTIONED EFFECTIVELY. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 10APR2024 REPORTED, THERE WAS NO HARM TO THE PATIENT.

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

  MAUDE report 19212487 ↗
• MalfunctionApr 30, 2024Decrease in Suction; Excess Flow or Over-Infusion; Unintended Deflation; Decrease in Suction; Excess Flow or Over-Infusion; Unintended Deflation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FOURTH OF TEN REPORTS. REFER TO 8030647-2024-00026 FOR THE FIRST REPORT. REFER TO 8030647-2024-00027 FOR THE SECOND REPORT. REFER TO 8030647-2024-00028 FOR THE THIRD REPORT. REFER TO 8030647-2024-00030 FOR THE FIFTH REPORT. REFER TO 8030647-2024-00031 FOR THE SIXTH REPORT. REFER TO 8030647-2024-00032 FOR THE SEVENTH REPORT. REFER TO 8030647-2024-00033 FOR THE EIGHTH REPORT. REFER TO 8030647-2024-00034 FOR THE NINTH REPORT. REFER TO 8030647-2024-00035 FOR THE TENTH REPORT. THE PARENT OF THE PATIENT REPORTED, THE AREA AROUND THE INLINE SUCTION CATHETER(S) WERE FILLING UP WITH AIR AND THEN COMPLETELY DEFLATED. THE CATHETER(S) WERE NOT EASILY REMOVED FROM THE PATIENT¿S TRACH AND THE PATIENT WAS NO ABLE TO BE SUCTIONED EFFECTIVELY. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 10APR2024 REPORTED, THERE WAS NO HARM TO THE PATIENT.

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

  MAUDE report 19212479 ↗
• MalfunctionApr 30, 2024Decrease in Suction; Excess Flow or Over-Infusion; Unintended Deflation; Decrease in Suction; Excess Flow or Over-Infusion; Unintended Deflation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED 10 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF TEN REPORTS. REFER TO 8030647-2024-00026 FOR THE FIRST REPORT REFER TO 8030647-2024-00027 FOR THE SECOND REPORT REFER TO 8030647-2024-00029 FOR THE FOURTH REPORT REFER TO 8030647-2024-00030 FOR THE FIFTH REPORT REFER TO 8030647-2024-00031 FOR THE SIXTH REPORT REFER TO 8030647-2024-00032 FOR THE SEVENTH REPORT REFER TO 8030647-2024-00033 FOR THE EIGHTH REPORT REFER TO 8030647-2024-00034 FOR THE NINTH REPORT REFER TO 8030647-2024-00035 FOR THE TENTH REPORT THE PARENT OF THE PATIENT REPORTED, THE AREA AROUND THE INLINE SUCTION CATHETER(S) WERE FILLING UP WITH AIR AND THEN COMPLETELY DEFLATED. THE CATHETER(S) WERE NOT EASILY REMOVED FROM THE PATIENT¿S TRACH AND THE PATIENT WAS NO ABLE TO BE SUCTIONED EFFECTIVELY. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 10APR2024 REPORTED, THERE WAS NO HARM TO THE PATIENT.

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

  MAUDE report 19212469 ↗
• InjuryApr 16, 2024Contamination; Material Integrity Problem; Contamination; Material Integrity Problem

  IT WAS REPORTED, A PIECE OF THE CLOSED SUCTION CATHETER (CSC), CAME OFF "INSIDE THE SUCTION" FOR A TRACH-PATIENT, NO INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 21 MAR2024 REPORTED, THE FLAPPER VALVE OF THE CSC WHICH HAD BEEN IN PLACE FOR 3 DAYS, BECAME DETACHED AND WENT INTO THE PATIENT'S AIRWAY DURING SUCTIONING, (WHEN THE PARENT WITHDREW THE CATHETER FROM THE CHILD'S AIRWAY, THE FLAPPER VALVE WAS NOTED TO BE ON THE TIP OF THE CATHETER). THE CSC WAS REPLACED WITH A NEW ONE. THE PATIENT DID NOT DESATURATE OR HAVE ANY OTHER ADVERSE EFFECTS; NO FURTHER MEDICAL INTERVENTIONS WERE REQUIRED, THE PATIENT REMAINS AT BASELINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19117847 ↗
• InjuryOct 18, 2023Material Integrity Problem; Material Integrity Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030647-2023-00119 FOR THE FIRST REPORT, REFER TO 8030647-2023-00120 FOR THE SECOND REPORT. THE PATIENT¿S PARENT REPORTED, THE PLASTIC SEEMED TO TEAR SUPER EASILY, ON THE CLOSED SUCTION CATHETER (CSC), CAUSING THE CATHETER TO BECOME EXPOSED AND THEIR DAUGHTER HAS GOTTEN MULTIPLE INFECTIONS. ADDITIONAL INFORMATION RECEIVED 03OCT2023 REPORTED, THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND NEBULIZED MEDICATIONS (TOBRAMYCIN) TO GET THE INFECTION UNDER CONTROL AND SHE WAS CURRENTLY DOING WELL AND WAS BACK TO NORMAL.

  Patient problems: Unspecified Infection

  MAUDE report 17961489 ↗
• InjuryOct 18, 2023Material Integrity Problem; Material Integrity Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 8030647-2023-00119 FOR THE FIRST REPORT. REFER TO 8030647-2023-00121 FOR THE THIRD REPORT. THE PATIENT¿S PARENT REPORTED, THE PLASTIC SEEMED TO TEAR SUPER EASILY, ON THE CLOSED SUCTION CATHETER (CSC), CAUSING THE CATHETER TO BECOME EXPOSED AND THEIR DAUGHTER HAS GOTTEN MULTIPLE INFECTIONS. ADDITIONAL INFORMATION RECEIVED 03OCT2023 REPORTED, THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND NEBULIZED MEDICATIONS (TOBRAMYCIN) TO GET THE INFECTION UNDER CONTROL AND SHE WAS CURRENTLY DOING WELL AND WAS BACK TO NORMAL.

  Patient problems: Unspecified Infection

  MAUDE report 17961482 ↗
• InjuryOct 18, 2023Material Integrity Problem; Material Integrity Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030647-2023-00120 FOR THE SECOND REPORT . REFER TO 8030647-2023-00121 FOR THE THIRD REPORT . THE PATIENT¿S PARENT REPORTED, THE PLASTIC SEEMED TO TEAR SUPER EASILY, ON THE CLOSED SUCTION CATHETER (CSC), CAUSING THE CATHETER TO BECOME EXPOSED AND THEIR DAUGHTER HAS GOTTEN MULTIPLE INFECTIONS. ADDITIONAL INFORMATION RECEIVED 03OCT2023 REPORTED, THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND NEBULIZED MEDICATIONS (TOBRAMYCIN) TO GET THE INFECTION UNDER CONTROL AND SHE WAS CURRENTLY DOING WELL AND WAS BACK TO NORMAL.

  Patient problems: Unspecified Infection

  MAUDE report 17961475 ↗
• MalfunctionAug 14, 2023Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  IT WAS REPORTED, THE CLOSED SUCTION CATHETER (CSC) WITH TORN SLEEVE RESULTED IN THE PATIENT DESATURATING; THE PATIENT REQUIRED MANUAL VENTILATION FROM A RESUSCITATION BAG DUE TO DESATURATION FROM THE LEAK WITHIN THE CIRCUIT. THE PATIENT¿S CURRENT STATUS WAS NOT PROVIDED; THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 25JUL2023 REPORTED, THE PATIENT¿S DESATURATION WAS DISCOVERED DUE TO THE VENTILATOR AND PATIENT SATURATION ALARM(S). THE CLOSED SUCTION CATHETER (CSC) WAS DOCUMENTED AS CHANGED ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED 26JUL2023 REPORTED, THE PATIENT REQUIRED MANUAL VENTILATION THROUGH A RESUSCITATION BAG FOR 3-4 MINUTES TO INCREASE SATURATION AND LOCATE THE LEAK IN THE CIRCUIT THROUGH THE CSC SLEEVE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 17546981 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S PARENT REPORTED, THE SLEEVES ARE HARD AND CAUSED ISSUES WITH SUCTIONING. THE PATIENT HAS DEVELOPED PNEUMONIA, FOR WHICH THEY ARE BEING TREATED WITH A THIRD ROUND OF ANTIBIOTICS; THE PATIENT¿S HEALTH WAS REPORTEDLY IMPROVING.

  Patient problems: Pneumonia

  MAUDE report 17112762 ↗
• InjuryMay 23, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE MOTHER THAT HER SON HAD ¿BACK-TO-BACK RESPIRATORY INFECTIONS.¿ THE MOST RECENT CULTURE TESTED POSITIVE FOR SERRATIA MARCESCENS BACTERIA. THE MOTHER BELIEVES THE INFECTION IS DUE TO THE CATHETER SLEEVE TEARING. ADDITIONAL INFORMATION RECEIVED FROM THE MOTHER ON 28APR2023 STATED THAT SPUTUM CULTURE RESULT INDICATED MODERATE GROWTH OF SERRATIA MARCESCENS. HER SON WAS PRESCRIBED BACTRIM 200-40MG/5ML SUSPENSION, 12ML BY MOUTH TWICE DAILY FOR TEN DAYS. ¿HIS CHEST SECRETIONS ARE STILL THICK AND COPIOUS, BUT THEY BACK TO CLEAR/WHITE IN COLOR.¿ NO FURTHER EVENTS OF INFECTION REPORTED. FDA VOLUNTARY MEDWATCH MW REPORT MW5117327 RECEIVED 11MAY2023, NO NEW INFORMATION REPORTED. FDA VOLUNTARY MEDWATCH MW REPORT MW5117269 RECEIVED 15MAY2023, NO NEW INFORMATION REPORTED.

  Patient problems: Respiratory Tract Infection

  MAUDE report 16983855 ↗
• MalfunctionMay 15, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE PLASTIC AROUND THE TRACH SUCTION CATHETER SPLIT, CREATING AN OPENING AND RESULTING IN DECREASED TIDAL VOLUMES. IT WAS NOT REPORTED IF ANY MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Low Oxygen Saturation

  MAUDE report 16933687 ↗
• MalfunctionApr 26, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE SUCTION CATHETER THUMB VALVE ¿DOES NOT RETRACT ALL THE WAY.¿ NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 16815526 ↗
• InjuryMar 21, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE PLASTIC WRAP AROUND THE 8FR INLINE SUCTION CATHETER FOR TRACH RIPPED OPEN AT THE SEAM (THE PLASTIC WASN'T SEALED) AND THE PATIENT REQUIRED INCREASED FRACTION OF INSPIRED OXYGEN (FIO2) (EARLIER IN THE SHIFT); THEY WERE ABLE TO WEAN THE PATIENT BACK DOWN TO BASELINE OXYGEN ADMINISTRATION..

  Patient problems: Low Oxygen Saturation

  MAUDE report 16587657 ↗
• MalfunctionMar 16, 2023Gas/Air Leak; Material Integrity Problem; Gas/Air Leak; Material Integrity Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOURTEEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOURTEEN DIFFERENT PATIENTS. THIS IS THE SIXTH OF FOURTEEN REPORTS. REFER TO 8030647-2023-00044 FOR THE FIRST REPORT, REFER TO 8030647-2023-00045 FOR THE SECOND REPORT, REFER TO 8030647-2023-00046 FOR THE THIRD REPORT, REFER TO 8030647-2023-00047 FOR THE FOURTH REPORT, REFER TO 8030647-2023-00048 FOR THE FIFTH REPORT, REFER TO 8030647-2023-00050 FOR THE SEVENTH REPORT, REFER TO 8030647-2023-00051 FOR THE EIGHTH REPORT, REFER TO 8030647-2023-00052 FOR THE NINTH REPORT, REFER TO 8030647-2023-00053 FOR THE TENTH REPORT, REFER TO 8030647-2023-00054 FOR THE ELEVENTH REPORT, REFER TO 8030647-2023-00055 FOR THE TWELFTH REPORT, REFER TO 8030647-2023-00056 FOR THE THIRTEENTH REPORT, REFER TO 8030647-2023-00057 FOR THE FOURTEENTH REPORT. IT WAS REPORTED, THE SLEEVE TORE DURING PATIENT USE AND WAS DISCOVERED BY LEAK(S) IN THE VENTILATOR; THERE WAS NO REPORTED INJURY; THE CATHETER WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 16559287 ↗