AVANOS 40778Recalls & reported problems
Avanos Medical, Inc. · ON-Q* Pain Relief System T-bloc* Echogenic Continuous Stimulating Nerve Block Tray · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00193494407780), received between Mar 16, 2022 and Sep 13, 2023 — 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
Device problems
- Break3
- Difficult to Remove1
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2023Break; Break
IT WAS REPORTED "AFTER PLACING CATHETER AND CONNECTING THE NEXUS CONNECTOR, THE CATHETER SHEARED AT NEXUS CONNECTION SITE. THE EXTERIOR OF CATHETER STRETCHED FROM THE INTERIOR SPIROL (SPIRAL) OF CATHETER. THE DEFECTIVE CATHETER WAS REMOVED FROM PATIENT." THERE WAS NO REPORTED INJURY.
Patient problems: Foreign Body In Patient
MAUDE report 17741014 ↗MalfunctionMar 16, 2022Break; Break
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH TWO SEPARATE PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2022-00013 FOR THE FIRST REPORT. IT WAS REPORTED THERE WAS AN INCIDENT OF POSSIBLE CATHETER SHEARING UPON REMOVAL. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DATE OF SURGERY (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED 08MAR2022 REPORTED THAT AT SOME POINT CATHETER A REMOVAL WAS ATTEMPTED AND APPROXIMATELY 4 CENTIMETERS OF THE CATHETER WAS LEFT INSIDE THE PATIENT. THERE WAS NO REPORTED INJURY.
Patient problems: Foreign Body In Patient
MAUDE report 13777209 ↗MalfunctionMar 16, 2022Break; Difficult to Remove; Break; Difficult to Remove
AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2022-00014 FOR THE SECOND REPORT. IT WAS REPORTED THERE WAS AN INCIDENT OF POSSIBLE CATHETER SHEARING UPON REMOVAL. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DATE OF SURGERY (B)(6) 2021. ADDITIONAL INFORMATION RECEIVED 08MAR2022 REPORTED THE PATIENT RETURNED TO THE HOSPITAL TO HAVE THE CATHETER REMOVED AND IT APPEARED TO BE NOT REMOVEABLE; IT WAS EXTRACTED WITH A PIECE OF THE RETAINED CATHETER LEFT BEHIND. THE PATIENT RETURNED FOR A FOLLOW UP APPOINTMENT AND IT WAS NOTED THAT THE PATIENT DID NOT EXPERIENCE ANY KNOWN COMPLICATIONS OR INFECTION; THE PATIENT WILL CONTINUE TO FOLLOW-UP AS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13777204 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.