MalfunctionIFP
PREFILLED FORMALIN CONTAINER 60 ML FILL IN 120 ML (4 OZ.)
Received Aug 9, 2022 · Event occurred Jun 15, 2022
Report 15191758 · MDR key 15191758
Device
Generic name
Formalin, Neutral Buffered
Manufacturer
E K Industries, Inc.Model number
24499-100X120MLLot number
2207503
Product problems
- Crack
- Device Damaged Prior to Use
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
UNPACKING NEW FORMALIN BOX AND NOTICED EMPTY FORMALIN BOTTLE, WHICH WAS CRACKED BUT BOX WAS DRY BOTTOM. LOT NUMBER 2207503. EXPIRY: YEAR 2024. BRAND EKI 120ML BOTTLE.