inforMED
MalfunctionNXA

MEDICAL ACTION INDUSTRIES

Received Apr 18, 2018 · Event occurred Apr 5, 2018

Report 7439477 · MDR key 7439477

Device

Generic name

Tracheotomy Care Kit

Model number

75378

Catalog number

75378

Lot number

239123

Product problems

  • Device Contamination with Chemical or Other Material

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

WHEN NEW TRACH CARE TRAY WAS OPENED, THERE IS BROWN SUBSTANCE ON THE CONTENTS OF THE PACKAGE. THE CONTENTS APPEAR DIRTY. THIS WAS NOT UTILIZED ON A PATIENT.