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AVANOS* 183A46Recalls & reported problems

Avanos Medical, Inc. · Whitacre 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 00193493905980), received between Jun 20, 2023 and Jun 20, 2023 — 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

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 20, 2023Break; Break

    IT WAS REPORTED THAT THE NEEDLE BROKE. NO INJURY REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 26MAY2023, THE NEEDLE BROKE DURING PATIENT USE. THE MD WAS ABLE TO REMOVE THE NEEDLE THAT REMAINED AFTER IT BROKE. THERE WAS NO INJURY TO THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED ON 12JUN2023 REPORTING, "THE SPINAL ANESTHESIA TECHNIQUE WAS PERFORMED BY A TRAINEE. AN INTRODUCER WAS USED. A REORIENTATION OF THE NEEDLE WAS MADE DURING THE TECHNIQUE. IT WAS DURING THE TRANSFER OF THE NEEDLE TO THE ANESTHETIST (MYSELF) TO FINALIZE/COMPLETE THE TECHNIQUE, THAT I FELT A SNAP AND WAS ABLE TO REMOVE THE NEEDLE AS A WHOLE BY REMOVING THE INTRODUCER IN THE SAME MOVEMENT."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17164952 ↗

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.