MalfunctionFLF
STERILANT CONCENTRATE
Received Apr 12, 1996 · Event occurred Apr 4, 1996
Report MW1008870 · MDR key 31976
Device
Product problems
- Fluid/Blood Leak
- Device Emits Odor
- Spillage, accidental
Patient
NO INFO
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
UPON OR NURSE'S AIDE (NA) CONTACT WITH MFR'S STERILANT CONTAINER FOR PLACEMENT IN MFR'S STERILANT MACHINE, CONTAINER SPONTANEOUSLY OPENED, RESULTING IN SPILLAGE OF SOLUTION ONTO NA AND SPREAD OF FUMES. NA EVALUATED IN ER AND ADMITTED TO HOSP OVERNIGHT.