inforMED
MalfunctionNWU

CARDINAL HEALTH

Received Jul 21, 2023 · Event occurred Apr 26, 2023

Report 17370404 · MDR key 17370404

Device

Generic name

Endoscope Introducer Kit

Model number

SBA13LCEMD

Catalog number

SBA13LCEMD

Lot number

987898

Product problems

  • Particulates
  • Device Damaged Prior to Use
  • Device Contaminated During Manufacture or Shipping

Patient

30 DA · Female

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

Narrative

Description of Event or Problem

FROM STAFF: DEBRIS/BURN/BUG FOUND IN RAYTEC ENDO PACK.