Skip to content

AVANOS 183A12Recalls & reported problems

Avanos Medical, Inc. · AVANOS* Tuohy Epidural Needle · Class 2

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 00193493905720), received between Jul 17, 2020 and Jul 17, 2020 — 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 17, 2020Break; Break

    IT WAS REPORTED THE EPIDURAL NEEDLE BROKE OFF IN THE PATIENT DURING THE PROCEDURE. THE BROKEN NEEDLE SEGMENT WAS REMOVED VIA A MEDICAL PROCEDURE. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 30-JUN-2020 STATED THE BREAK WAS IN THE MIDDLE OF THE NEEDLE. THE PHYSICIAN MADE A SMALL 1CM INCISION AND THE BROKEN NEEDLE WAS REMOVED, UNDER FLUOROSCOPY GUIDANCE, WITH A SPECIAL INSTRUMENT AND THE SITE WAS SUTURED. THE PATIENT EXPERIENCED NO PERMANENT DAMAGE. THE PATIENT WILL FOLLOW-UP WITH A PHYSICIAN AND THE SPINE SURGEON FOR EVALUATION OF THE INCISION SITE.

    Patient problems: Foreign Body In Patient

    MAUDE report 10290168 ↗

Other NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) devices

All NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.