BURKHART PRIVATE LABEL ADVANTAGE SALIVA EJECTOR
Received Jul 10, 2015 · Event occurred Jul 9, 2015
Report 2433773-2015-00001 · MDR key 4907329
Product problems
- Detachment Of Device Component
- Component Falling
- Difficult to Remove
Patient
Not reported
- Aspiration/Inhalation
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
THE FACILITY REPORTED A TIP THAT FELL OFF OF A SALIVA EJECTOR DURING A DENTAL PROCEDURE. THE PATIENT ASPIRATED THE TIP AND IT LODGED IN THE PATIENT'S LUNG. SURGERY WAS REQUIRED TO REMOVE THE TIP. CROSSTEX QA AND MANUFACTURING EVALUATIONS ARE UNDERWAY AND CROSSTEX IS STILL IN CLOSE COMMUNICATION WITH THE DISTRIBUTOR. THERE ARE NO OTHER ADVERSE EVENTS RELATED TO THIS PRODUCT. PATIENT CONDITION IS UNKNOWN AT THIS TIME. THIS COMPLAINT WILL CONTINUE TO BE MONITORED AND MAINTAINED BY THE CROSSTEX COMPLAINT HANDLING SYSTEM.
Additional Manufacturer Narrative
THE FACILITY REPORTED A TIP THAT FELL OFF OF A SALIVA EJECTOR DURING A DENTAL PROCEDURE. THE PATIENT ASPIRATED THE TIP AND IT LODGED IN THE PATIENT'S LUNG. SURGERY WAS REQUIRED TO REMOVE THE TIP. CROSSTEX QA AND MANUFACTURING EVALUATIONS ARE UNDERWAY AND CROSSTEX IS STILL IN CLOSE COMMUNICATION WITH THE DISTRIBUTOR. THERE ARE NO OTHER ADVERSE EVENTS RELATED TO THIS PRODUCT. PATIENT CONDITION IS UNKNOWN AT THIS TIME. THIS COMPLAINT WILL CONTINUE TO BE MONITORED AND MAINTAINED BY THE CROSSTEX COMPLAINT HANDLING SYSTEM. A VOLUNTARY RECALL OF THE PROBLEM DEVICE LOT WAS INITIATED ON 17 JULY 2015 BY (B)(4).
Description of Event or Problem
THE FACILITY REPORTED A TIP THAT FELL OFF OF A SALIVA EJECTOR DURING A DENTAL PROCEDURE. THE PATIENT ASPIRATED THE TIP AND IT LODGED IN THE PATIENT'S LUNG. SURGERY WAS REQUIRED TO REMOVE THE TIP.
Description of Event or Problem
THE FACILITY REPORTED A TIP THAT FELL OFF OF A SALIVA EJECTOR DURING A DENTAL PROCEDURE. THE PATIENT ASPIRATED THE TIP AND IT LODGED IN THE PATIENT'S LUNG. SURGERY WAS REQUIRED TO REMOVE THE TIP.
Remedial action
- Recall
- Patient Monitoring