AVANOS* 46853Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00193494468538), received between Jul 21, 2022 and Jul 21, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2022Break; Break

  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 2026095-2022-00069 FOR THE FIRST EVENT. REFER TO 2026095-2022-00070 FOR THE SECOND EVENT. ONE ADDITIONAL ON-Q CATHETER BROKE UPON ON REMOVAL OUTSIDE OF THE PATIENT. THE PATIENT WAS AWAITING ABDOMINAL X-RAY WHEN REVIEWED THE DAY AFTER ATTEMPTED REMOVAL. THE REMAINING PART OF THE CATHETER HAD MIGRATED OUT OF INSERTION SITE ENOUGH TO REMOVE. THE DEVICE WAS IN USE FOR 2 DAYS.

  Patient problems: Foreign Body In Patient

  MAUDE report 15080438 ↗
• MalfunctionJul 21, 2022Break; Break

  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 2026095-2022-00070 FOR THE SECOND EVENT. REFER TO 2026095-2022-00081 FOR THE THIRD EVENT. IT WAS REPORTED THE PATIENT HAD A CATHETER THAT HAD BEEN LEAKING ON THE LEFT SIDE, AND NOW HAD A BROKEN CATHETER. ON REVIEW OF THE PATIENT THE CATHETER HAD BEEN CLEANLY BROKEN/SNAPPED UNDER THE NR [NEURAXIAL] FIT CONNECTOR AT THE FIRST OVERLAPPING SECTION. THE REMAINING CATHETER WAS STILL INSERTED INTO THE PATIENT AND WAS NOT COVERED. NO STRETCHING OF THE CATHETER APPARENT. THE ON-Q PUMP WAS STILL ATTACHED TO THE RIGHT ABDOMINAL CATHETER RUNNING AT 7 ML/H AS PER PRESCRIPTION. THE REMAINING GIVING SET (FROM THE LEFT CATHETER) WAS CLAMPED AND STILL RETAINED THE BROKEN NR FIT CONNECTOR. THE BROKEN SECTION OF CATHETER INCLUDING NR FIT CONNECTOR WAS RETAINED IN SPECIMEN BAG AND PATIENT LABEL ATTACHED. THE NR FIT CAP WAS ATTACHED ONTO THE ON-Q PUMP GIVING SET. THE CATHETER FROM THE LEFT ABDOMEN WAS UNUSABLE AND THEREFORE WAS TO BE REMOVED. REMOVAL ATTEMPTED BY THE CLINICIAN WHO GENTLY APPLIE

  Patient problems: Foreign Body In Patient

  MAUDE report 15080405 ↗
• MalfunctionJul 21, 2022Break; Break

  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 2026095-2022-00069 FOR THE FIRST EVENT. REFER TO 2026095-2022-00081 FOR THE THIRD EVENT. ONE ADDITIONAL ON-Q CATHETER BROKE UPON ON REMOVAL OUTSIDE OF THE PATIENT. THE PATIENT WAS AWAITING ABDOMINAL X-RAY WHEN REVIEWED THE DAY AFTER ATTEMPTED REMOVAL. THE REMAINING PART OF THE CATHETER HAD MIGRATED OUT OF INSERTION SITE ENOUGH TO REMOVE. THE DEVICE WAS IN USE 3 DAYS.

  Patient problems: Foreign Body In Patient

  MAUDE report 15080371 ↗