inforMED
MalfunctionBSP

PENCAN

Received Nov 5, 2024 · Event occurred Oct 16, 2024

Report 20609263 · MDR key 20609263

Device

Generic name

Needle, Conduction, Anesthetic (w/wo Introducer)

Model number

333875

Catalog number

333875

Lot number

0061795871

Patient

2 MO · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

25G SPINAL NEEDLE BROKE WHEN WITHDRAWN OUT OF THE INTRODUCER NEEDLE. INTRODUCER NEEDLE THEN WITHDRAWN, AND THE REST OF THE SPINAL NEEDLE CAME OUT WITH THE INTRODUCER. THE REST OF THE SPINAL NEEDLE WAS INTACT. MANUFACTURER RESPONSE FOR SPINAL NEEDLE, PECAN PENCIL POINT SPINAL NEEDLE (PER SITE REPORTER). UNKNOWN.