inforMED
MalfunctionBSP

AVANOS EPIDURAL TUOHY NEEDLE

Received Jul 7, 2025 · Event occurred May 8, 2025

Report MW5172266 · MDR key 22412222

Device

Generic name

Needle, Conduction, Anesthetic (w/wo Introducer)

Model number

18324

Lot number

30350230

Product problems

  • Fracture

Patient

59 YR · Female

  • Device Embedded In Tissue or Plaque
  • Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

DURING A ROUTINE L4¿L5 LUMBAR EPIDURAL STEROID INJECTION USING A 20-GAUGE, 4.5-INCH SPINAL NEEDLE, I OBSERVED THAT THE NEEDLE FRACTURED NEAR THE HUB DURING ADVANCEMENT, LEAVING A PORTION OF THE NEEDLE RETAINED IN THE PATIENT'S SOFT TISSUE. UNDER STERILE TECHNIQUE AND FLUOROSCOPIC GUIDANCE, DOCTOR (DR.) CAREFULLY LOCATED AND SUCCESSFULLY REMOVED THE RETAINED NEEDLE FRAGMENT. THE PATIENT REMAINED STABLE AND COOPERATIVE THROUGHOUT THE PROCEDURE. NO SEDATIVES OR ADDITIONAL INTERVENTIONS WERE REQUIRED.