inforMED
MalfunctionDYN

SALIVA EJECTOR

Received Dec 28, 1995

Report MW4000982 · MDR key 29100

Device

Generic name

Saliva Ejector

Manufacturer

Henry Schein, Inc.

Lot number

100-5205

Product problems

  • Detachment Of Device Component

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

ON SEVERAL OCCASIONS THE END OF THE SUCTION TIP HAS COME DETACHED AND FALLEN INTO THE PT'S MOUTH. THIS COULD RESULT IN A SERIOUS INJURY IF A PT ASPIRATES OR SWALLOWS THE END OF THE TIP. ITEMS WERE RETURNED TO MFR FOR CREDIT. FACILITY HAS RECEIVED NO OTHER QUALITY OR PACKAGING COMPLAINTS ON SUBJECT SALIVA EJECTOR WHICH INDICATES THAT THIS IS AN ISOLATED INCIDENT.