inforMED
MalfunctionIFP

FORMALIN

Received Apr 12, 2022 · Event occurred Feb 14, 2022

Report 14083549 · MDR key 14083549

Device

Generic name

Formalin, Neutral Buffered

Catalog number

NB0507

Product problems

  • Crack

Patient

Unknown

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

Narrative

Description of Event or Problem

STATLAB 20 ML FORMALIN CONTAINERS HAVE A CRACK IN THE LID FOR TWO SEPARATE PATIENTS. PATHOLOGY TESTS WERE ABLE TO BE PERFORMED AND NO HARM TO PATIENTS OCCURRED. I DO NOT KNOW IF IT WAS PRODUCT RELATED OR USER CLOSED THE LID TOO TIGHT. SPECIMEN PART A SMALL BOWEL BIOPSY SPECIMEN PART D GASTRIC POLYP.