OtherFKY
MINNTECH
Received Jun 6, 1994 · Event occurred May 2, 1994
Report 2243621-1994-00115 · MDR key 19317
Device
Generic name
Ventable Blood Port Cap
Manufacturer
Minntech CorpCatalog number
35-8208-7
Lot number
UNKNOWN
Product problems
- Leak/Splash
- Reaction
- Difficult to Remove
Patient
35 YR
- Burn(s)
- Itching Sensation
- Reaction, systemic
Narrative
Description of Event or Problem
FACILITY ALLEGES THAT BLOOD PORT AND DIALYSATE PORT CAPS ARE DIFFICULT TO REMOVE, ONCE IN PLACE. THIS HAS RESULTED IN FORMALDEHYDE SPILLS, CAUSING FORMALDEHYDE REACTION IN CLINIC EMPLOYEE. SYMPTOMS INCLUDE CHEST TIGHTNESS, DRY THROAT, EYE IRRITATION, AND TINGLING SKIN.