AVANOS 13739Recalls & reported problems
Avanos Medical, Inc. · ON-Q* Disposable Tunneler & Sheaths · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00193494137397), received between Jul 13, 2021 and Jul 13, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2021Break; Break
IT WAS REPORTED WHILE THE PHYSICIAN WAS PLACING A CATHETER VIA A TUNNELER/INTRODUCER FOR AN INTERCOSTAL NERVE BLOCK. AFTER TUNNELING THE CATHETER, THE PHYSICIAN SNAPPED THE TOP OF THE T-PEEL SHEATH AND BEGAN TO REMOVE IT. THE T-PEEL BROKE LEAVING THE MAJORITY OF THE BROKEN DEVICE INSIDE OF THE PATIENT. THE SURGEON TOOK THE PATIENT BACK TO THE OPERATING ROOM OR AND REMOVED THE REMAINING SHEATH. THERE WAS NO REPORTED INJURY.
Patient problems: Foreign Body In Patient
MAUDE report 12163306 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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