MalfunctionMEF

GUMDROP

Received Oct 17, 2019 · Event occurred Jul 19, 2019

Report 9202849 · MDR key 9202849

Device

Generic name

Ring, Teething, Non-fluid Filled

Manufacturer

Natus Medical Incorporated

Product problems

Problem with Sterilization

Patient

180 DA

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

Narrative

Description of Event or Problem

PACIFIER NEEDS TO BE STERILIZED IN BOILING WATER FOR 5 MINUTES PER INSTRUCTIONS ON BAG, NOT READY FOR USE OUT OF BAG. WE HAVE NO ABILITY TO STERILIZE PACIFIER IN BOILING WATER IN THE UNIT. THE GREEN PREEMIE PACIFIER DOES NOT REQUIRE STERILIZATION AND STATES IS READY TO US OUT OF BAG. THIS ORANGE ONE DOES NOT. SONOGRAPHER CONCERNED THAT THESE ARE BEING USED THROUGHOUT THE HOSPITAL.