inforMED
MalfunctionCAZ

ARROW EPIDURAL CATHETERIZATION KIT

Received Jun 30, 2026 · Event occurred May 11, 2026

Report 9680794-2026-00497 · MDR key 25666176

Device

Generic name

Anesthesia Conduction Catheter

Catalog number

SJ-05501

Lot number

UNKNOWN

Product problems

  • Unsealed Device Packaging

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

(B)(4)

Description of Event or Problem

IT WAS REPORTED THAT "STERILE WRAP WAS NOT COMPLETELY TUCKED IN AND INTERFERED WITH THE TRAY BEING PROPERLY PACKAGED." NO PATIENT INVOLVEMENT.