MalfunctionIFP

FORMALIN CONTAINER 60ML

Received Nov 20, 2023 · Event occurred Jul 3, 2023

Report 18169633 · MDR key 18169633

Device

Generic name

Formalin, Neutral Buffered

Manufacturer

E K Industries, Inc.

Model number

24499-100X60ML

Lot number

2215441

Patient

Unknown

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

FORMALIN CONTAINER FOUND WITH BROKEN LID. ALMOST ENTIRE PLASTIC CIRCLE IN CENTER OF LID BROKEN. MANUFACTURER RESPONSE FOR 60ML CONTAINER, 60ML CONTAINER (PER SITE REPORTER). MFG ACKNOWLEDGED THEY WOULD LOOK INTO IT AND FIX, FAILED TO FIX. WE ARE CONVERTING TO A MEDLINE PRODUCT DUE TO ONGOING ISSUES SINCE [REDACTED DATE].