inforMED
MalfunctionGDY

MEDLINE 18"X18" LAP SPONGES

Received Jul 18, 2025 · Event occurred May 28, 2025

Report 22541561 · MDR key 22541561

Device

Generic name

Gauze/sponge, Internal, X-ray Detectable

Product problems

  • Incomplete or Missing Packaging

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

NO PATIENT HARM INCORRECT PACKAGING OF 18X18 LAP SPONGES MISSING THE SCAN WRAP FOR DOCUMENTATION. SPONGERS WERE OPEN ONTO THE STERILE FIELD APPROPRIATELY, WHEN NOTICED THE SCAN WRAP WAS NOTICED, I SHOWED THEM TO THE TEAM AND PUT THEM OUTSIDE OF THE OPERATING ROOM FOR DOCUMENTATION OF THIS SAFETY EVENT. 5 SPONGES EFFECTED: 1. STVK9N 2. STVQ8Q 3. STV1CP 4. SUO1HS 5. STVKTF LOT NUMBER NOT AVAILABLE AS THE WRAPPER WAS NOT PRESENT.