MalfunctionIFP
FORMALIN CONTAINER
Received Jun 30, 2023 · Event occurred Feb 14, 2023
Report 17236722 · MDR key 17236722
Device
Generic name
Formalin, Neutral Buffered
Manufacturer
E K Industries, Inc.Model number
4499100X60MLLot number
2236109
Product problems
- Contamination
Patient
Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
EKI 10% FORMALIN FIXATIVE 60ML, LOT# 2236109, EXP# [REDACTED DATE] UNUSED BOTTLE HAD THINGS IN THE FORMALIN BOTTLE. MANUFACTURER RESPONSE FOR FORMALIN CONTAINER, FORMALIN CONTAINER (PER SITE REPORTER). ONGOING ISSUE AT THE TIME.