inforMED
MalfunctionIFP

CARDINAL HEALTH PREFILLED FORMALIN SPECIMEN CONTAINER 180ML

Received Apr 11, 2025 · Event occurred Apr 4, 2025

Report MW5168881 · MDR key 21825340

Device

Generic name

Formalin, Neutral Buffered

Manufacturer

Cardinal Health

Lot number

147412

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.