inforMED
MalfunctionIFP

CARDINAL HEALTH

Received May 15, 2025 · Event occurred Apr 21, 2025

Report 22024631 · MDR key 22024631

Device

Generic name

Formalin, Neutral Buffered

Lot number

C4320-101

Product problems

  • Device label look-alike

Patient

NA · Unknown

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

Narrative

Description of Event or Problem

10% FORMALIN WAS DELIVERED TO THE PROCEDURAL AREA AND REPROCESSING LOCATIONS INSTEAD OF 70% ISOPROPYL ALCOHOL. BOTH CONTAINERS (10% FORMALIN AND 70% ISOPROPYL ALCOHOL) HAVE SIMILAR APPEARANCE. THE 10% FORMALIN WAS INADVERTENTLY USED WHEN ADDING FLUID TO THE 70% ISOPROPYL ALCOHOL CONTAINER, RESULTING IN ENDOSCOPES BEING REPROCESSED WITH THE INCORRECT FLUID. WE RECOMMEND CHANGING THE JUGS TO MAKE THEM MORE DISTINGUISHABLE.