MalfunctionIFP
CARDINAL HEALTH PREFILLED FORMALIN SPECIMEN CONTAINER 180ML
Received Apr 11, 2025 · Event occurred Apr 3, 2025
Report MW5168894 · MDR key 21826404
Device
Product problems
- Leak/Splash
- 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. THIS FACILITY HAS NOTED THIS CONCERN WITH LOT # 147838, EXP 10/2028.