Module 16 2022

The road from cause to harm Example 2

EO

Hazardous Situation: Exposure of Allergens/irritants in direct contact vitreous body Hazard: Bio-incompatible material into syringe

Harm to user: Systemic allergic response. Systemic toxicity / inflammatory response Fever

Cause : Sensor failure

Failure: Container Closure System is damaged and not noticed Effect: CCS is not tight and EO enters into barrel during sterilization