450 SAL EJECTOR 3283
Received Mar 22, 2024 · Event occurred Mar 11, 2024
Report 9612030-2024-00050 · MDR key 18960545
Device
Generic name
Mouthpiece, Saliva Ejector
Manufacturer
Cardinal HealthModel number
8881450004Catalog number
8881450004
Lot number
UNKNOWN
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
THE CUSTOMER REPORTED THAT DURING ORAL SUCTIONING, THE PLASTIC PART ON THE EDGE CAME OFF. THE PATIENT SWALLOWED THE FALLEN PART ACCIDENTALLY, AND, EVENTUALLY IT WAS RETRIEVED WITH AN ENDOSCOPE. THERE WAS NO ADDITIONAL MEDICATION OR NO FURTHER MEDICAL TREATMENT. THE PATIENT APPEARED TO BE ADVANCED AGE SINCE HE/SHE HAS NO TEETH AT ALL. THE PERIOD OF USE WAS A COUPLE OF MINUTES. THERE WAS NO INFECTION. IT DID FALL/RETAIN IN THE BODY. THERE IS NO FURTHER INFORMATION AVAILABLE.
Additional Manufacturer Narrative
A SAMPLE WAS RECEIVED AT THE PLANT FOR THE INVESTIGATION. BECAUSE A LOT NUMBER WAS NOT PROVIDED, THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. UPON A VISUAL EVALUATION OF THE SAMPLE, THE REPORTED ISSUE WAS CONFIRMED; DETACHMENT WAS OBSERVED BETWEEN THE TUBE AND CONNECTOR. A ROOT CAUSE WAS UNABLE TO BE DETERMINED. ACTIONS HAVE BEEN TAKEN TO ADDRESS THE REPORTED CONDITION. A QUALITY ALERT WAS ALSO ISSUED TO ALERT MANUFACTURING PERSONNEL AS PART OF THE QUALITY CONTAINMENT.