inforMED
MalfunctionIFP

PREFILLED FORMALIN SPECIMEN CONTAINER 180ML

Received Apr 16, 2025 · Event occurred Apr 8, 2025

Report MW5169125 · MDR key 21850299

Device

Generic name

Formalin, Neutral Buffered

Manufacturer

Cardinal Health

Lot number

221050

Product problems

  • Leak/Splash

Patient

NA · Unknown

  • Insufficient Information
  • Insufficient Information

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, MW5169126.