inforMED
MalfunctionDYN

PATTERSON SALIVA EJECTOR

Received Aug 26, 2005 · Event occurred Jul 5, 2005

Report 636387 · MDR key 636387

Device

Generic name

Saliva Ejector

Manufacturer

Patterson Dental

Model number

*

Catalog number

0894089

Lot number

*

Product problems

  • Detachment Of Device Component

Patient

21 YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

WHILE SUCTIONING THE PATIENT DURING A GASTROSCOPY, THE PATIENT BECAME COMBATIVE, PULLED THE GASTROSCOPE OUT, AND THE BLUE TIP OF THE PATTERSON SALIVA EJECTOR DETACHED IN THE PATIENT'S MOUTH. THERE IS RISK OF ASPIRATION IN A SEDATED PATIENT. THE RN MANUALLY REMOVED THE BLUE TIP FROM THE SEDATED PATIENT'S MOUTH. UPPER GI PROCEDURE OF STOMACH COULD NOT BE PERFORMED DUE TO PATIENT'S INTOLERANCE. PATIENT HAD NO INJURY. AFTER THIS OCCURRENCE, ALL OF THE REMAINING PATTERSON SALIVA EJECTORS WERE REMOVED AND REPLACED WITH FLEXIBLE BRONCHOSCOPY TYPE SUCTION DEVICES. A SAMPLE OF THE PATTERSON SALIVA EJECTOR FROM THE SAME BOX WILL BE SENT TO THE BRANCH OPERATIONS MANAGER. THE DEVICE INVOLVED IN THE OCCURRENCE WAS DISCARDED BECAUSE OF SALIVA CONTAMINATION.