inforMED
MalfunctionFPK

Q2

Received Jun 15, 2018 · Event occurred May 30, 2018

Report 7605349 · MDR key 7605349

Device

Generic name

Iv Extension Set

Model number

NA

Catalog number

95906

Lot number

054872

Product problems

  • Detachment Of Device Component
  • Physical Resistance

Patient

66 YR

  • Exposure to Body Fluids
  • Exposure to Body Fluids

Narrative

Description of Event or Problem

NURSE WAS FLUSHING THE LINE AND THERE WAS A "SUDDEN RESISTANCE" AT WHICH TIME THE CAP CAME OFF AND FLUID SPRAYED OUT OF THE PIVO CONNECTION PORT INTO HER EYE, FACE AND ARM.