inforMED
OtherKPP

MINNTECH

Received Jun 6, 1994 · Event occurred May 2, 1994

Report 2243621-1994-00113 · MDR key 19308

Device

Generic name

Ventable Blood Port Cap

Manufacturer

Minntech Corp.

Catalog number

35-8208-7

Lot number

UNKNOWN

Product problems

  • Leak/Splash
  • Reaction
  • Difficult to Remove

Patient

38 YR

  • Burn(s)
  • Itching Sensation
  • Reaction, systemic

Narrative

Description of Event or Problem

FACILITY ALLEGES THAT BLOOD PORT AND DIALYSATE PORT CAPS ARE DIFFERENT TO REMOVE, ONCE IN PLACE. THIS HAS RESULTED IN FORMALDEHYDE SPILLS, CAUSING FORMALDEHYDE REACTION IN CLINIC EMPLOYEE. SYMPTOMS INCLUDE BURNING AND ITCHING OF SKIN AND EYES AND HEADACHES.