MalfunctionIFP
BAXTER DIAGNOSTICS
Received Oct 21, 1997 · Event occurred Sep 22, 1997
Report 128212 · MDR key 128212
Device
Generic name
S/p Pre-filled Buffered 10% Formalin
Manufacturer
Richard-allen ScientificModel number
*Catalog number
4320-90B
Lot number
97H26
Product problems
- Fluid/Blood Leak
- Unsealed Device Packaging
Patient
NA
Narrative
Description of Event or Problem
EMPLOYEE IN DISTRIBUTION LIFTED BOX TO SHOULDER AND FELT WETNESS; ON CHECKING BOX OF FORMALIN, IDENTIFIED # OF 90CC CONTAINERS LEAKING. ON FURTHER EXAM, SECOND EMPLOYEE EXPOSED ON HANDS. FIRST EMPLOYEE CHANGED SHIRT AND CLEANED SHOULDER; SECOND EMPLOYEE WASHED HANDS.