inforMED
DYN

450 SAL EJECTOR 3283

Received Oct 4, 2004

Report 9612030-2004-00005 · MDR key 916506

Device

Generic name

Dental

Model number

*

Catalog number

8881450004

Lot number

412606364

Product problems

  • Detachment Of Device Component
  • Tip breakage

Patient

*

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

Narrative

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION OF THE INVESTIGATION, RESULTS WILL BE FORWARDED.

Description of Event or Problem

IT WAS REPORTED TO TYCO HEALTHCARE / KENDALL THAT A CUSTOMER EXPERIENCED A PROBLEM WITH THE SALIVA ENJECTORS. THE CUSTOMER REPORTS THAT THE BLUE TIP DETACHED FROM THE EJECTOR IN THE AIRWAY OF A PATIENT.