inforMED
MalfunctionGDY

MEDLINE

Received Oct 28, 2025 · Event occurred Sep 11, 2025

Report 23402485 · MDR key 23402485

Device

Generic name

Gauze/sponge, Internal, X-ray Detectable

Model number

NON21430LF

Catalog number

NON21430LF

Product problems

  • Material Frayed

Patient

44 YR · Unknown

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

Narrative

Description of Event or Problem

SURGERY STARTED AND SURGEON USING RAYTECS. SCRUB TECH NOTICED THAT THE RAYTEC WAS EASILY FRAYING. SCRUB TECH MADE THE WHOLE TEAM AWARE AND TOOK THE DEFECTIVE RAYTECS OFF THE FIELD. REGISTERED NURSE PROVIDED NEW RAYTECS. SCRUB TECH CONFIRMED NEW RAYTECS WERE NOT FRAYING.