inforMED
MalfunctionDYN

450 SAL EJECTOR 3283

Received Aug 21, 2009

Report 9612030-2009-00025 · MDR key 1493979

Device

Generic name

Saliva Ejector

Manufacturer

Covidien

Model number

8881450004

Catalog number

8881450004

Lot number

900703264

Product problems

  • Detachment Of Device Component

Patient

UNK

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

IT WAS REPORTED TO COVIDIEN ON 08/14/2009 THAT A CUSTOMER HAD AN ISSUE WITH A SALIVA EJECTOR. THE CUSTOMER STATES THE TIP FELL OFF IN A PT'S MOUTH.

Additional Manufacturer Narrative

(B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.