MalfunctionIFP
CARDINAL HEALTH PREFILLED FORMALIN SPECIMEN CONTAINER 180ML
Received Apr 22, 2025 · Event occurred Apr 9, 2025
Report MW5169418 · MDR key 21884407
Device
Product problems
- Leak/Splash
- Chemical Problem
- Contamination of Device Ingredient or Reagent
- Fail-Safe Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CARDINAL HEALTH 180ML FORMALIN CONTAINERS LEAKING INTO SPECIMEN BAGS. SPECIMEN CONTAINERS ARE SECURED TIGHTLY. LEAKING SPECIMENS POSE A RISK TO PATIENT SAFETY (LOSS OF SPECIMEN OR DEGRADATION OF SPECIMEN) AND A SAFETY RISK TO LABORATORY AND TRANSPORT PERSONNEL. NO SPECIMEN LOSS HAS BEEN REPORTED. SPECIMEN CONTAINER RECEIVED LEAKING FORMALIN. LOT # 147437 EXP:10/28.