MalfunctionIFP
CARDINAL HEALTH PREFILLED FORMALIN SPECIMEN CONTAINER 180ML
Received Apr 11, 2025 · Event occurred Apr 4, 2025
Report MW5168881 · MDR key 21825340
Device
Product problems
- Fluid/Blood Leak
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 #S 147412, EXP 09/28 AND 145992, EXP 09/28. REFERENCE REPORT: MW5168882.