MalfunctionIFP

FORMALIN CONTAINER

Received Jul 28, 2023 · Event occurred Jul 3, 2023

Report 17419638 · MDR key 17419638

Device

Generic name

Formalin, Neutral Buffered

Manufacturer

E K Industries, Inc.

Model number

24499-100X60ML

Lot number

2215441, 2229926

Patient

Unknown

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

Narrative

Description of Event or Problem

6 FORMALIN JARS FOUND IN DRAWER WITH CRACKED LIDS ALL WITH LOT# 2215441 EXP [REDACTED DATE]. ADDITIONAL FORMALIN CONTAINER WAS FOUND TO HAVE LARGE CRACK IN LID. LOT# 2229926 EXP [REDACTED DATE]. MANUFACTURER RESPONSE FOR FORMALIN CONTAINER, (BRAND NOT PROVIDED) (PER SITE REPORTER) NOTIFIED THEM IN JANUARY, ESCALATED IT TO THEM OR CORRECTION. ALREADY CONVERTING TO A DIFFERENT BRAND DUE TO ONGOING ISSUES AND CONCERNS.