MalfunctionIFP
PREFILLED FORMALIN SPECIMEN CONTAINER 180ML
Received Apr 16, 2025 · Event occurred Apr 8, 2025
Report MW5169126 · MDR key 21850321
Device
Product problems
- Leak/Splash
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 147858 EXP 10/2028, 221050 EXP 2/29/2028, AND 217915 EXP 1/31/2028. REFERENCE REPORTS: MW5169124, MW5169125.