inforMED
MalfunctionGDY

RAYTEC SPONGE

Received Sep 25, 2024 · Event occurred Sep 20, 2024

Report 20300106 · MDR key 20300106

Device

Generic name

Gauze/sponge, Internal, X-ray Detectable

Lot number

24E044262 AND 24E044362

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

USED SPONGES WERE THROWN ON TO DROP ZONE. THE CIRCULATOR NOTICED WHEN HANGING THEM INTO THE COUNTER BAG THAT ONE WAS MISSING BLUE X RAY STRING. THE AREAS WAS SEARCHED, THE CIRCULATOR FOUND THE STRING ON THE FLOOR NEAR THE DROP ZONE. MORE SPONGES WERE EXAMINED AND FOUND TO HAVE THE BLUE DETECTABLE STRING FALLING OUT. ANOTHER SET WAS OPENED WITH THE SAME ISSUE. THE STRING CAN BE EASILY PULLED OUT, THEY COULD BE POTENTIALLY LEFT IN A PATIENT IF THE STRING WOULD BE SEPARATED. MANAGEMENT WAS CALLED TO THE OR TO ACKNOWLEDGE THE ISSUE. SPONGE COUNT WAS CORRECT AT THE END OF CLOSURE FOR THE PROCEDURE.