AVANOS 183A28Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193493905850), received between Dec 7, 2022 and May 25, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  THE RADIOLOGIC TECHNOLOGIST REPORTED, DURING AN INTERLAMINAR EPIDURAL OF THE LOWER LUMBAR A NEEDLE BROKE OFF IN THE PATIENT; THE PHYSICIAN WAS ABLE TO RETRIEVE THE REMAINING PORTION. THE PHYSICIAN STATED THAT UPON ADVANCING THE NEEDLE THERE WAS A POINT, WELL BEFORE REACHING THE TARGETED AREA WHERE THE NEEDLE BEGAN TO BEND, WHEN THE PHYSICIAN PULLED THE NEEDLE BACK IT SNAPPED (NEAR THE LOWER 1/3 FROM THE HUB).

  Patient problems: Foreign Body In Patient

  MAUDE report 17006065 ↗
• MalfunctionDec 7, 2022Material Integrity Problem; Material Integrity Problem

  FDA MEDWATCH /FDA USER FACILITY REPORT # MW5113070 REPORTED, ¿UPON REMOVAL OF [THE] EPIDURAL NEEDLE FROM [THE] PATIENT'S BACK, (USED FOR EPIDURAL BLOOD PATCH), IT BECAME EVIDENT THAT A PORTION OF THE NEEDLE HAD BROKEN OFF AND REMAINED IN THE PATIENT'S BACK. INTERVENTIONAL RADIOLOGY PHYSICIANS WERE CALLED TO THE PROCEDURE ROOM AND WERE ABLE TO SUCCESSFULLY REMOVE THE BROKEN PORTION OF THE NEEDLE FROM THE PATIENT.¿ NO INJURY REPORTED

  Patient problems: Foreign Body In Patient

  MAUDE report 15936879 ↗