450 SAL EJECTOR 3283
Received Aug 3, 2007 · Event occurred Jun 29, 2007
Report 9612030-2007-00038 · MDR key 889024
Device
Generic name
Sal Ejector
Manufacturer
Tyco/kendall HealthcareModel number
8881450004Catalog number
8881450004
Lot number
513506064
Product problems
- Detachment Of Device Component
Patient
YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED TO TYCO/KENDALL HEALTHCARE THAT A CUSTOMER HAD A PROBLEM WITH THE SAL EJECTOR. THE CUSTOMER STATED: THE TIP PART WAS DETACHED AND LOST IN USE. THE PT WAS UNCONSCIOUS AND TRANSPORTED TO THE EMERGENCY ROOM, THEREFORE THE PT WAS NOT ABLE TO SPIT OUT ANY FOREIGN MATERIAL IN HIS MOUTH. TO FIND THE TIP FELL OFF, THE CUSTOMER TOOK AN X-RAY, BUT IT COULD NOT BE FOUND. TWO DAYS LATER, DURING THE ORAL CARE ON THE PT, THE TIP WAS FOUND. NO HARM ON THE PT CAUSED BY THIS INCIDENT.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION, THE RESULTS WILL BE FORWARDED.