MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-18 for BURKHART SALIVA EJECTORS * manufactured by Burkhart.
[5864576]
The tip of a saliva evacuator fell off and into the oropharynx of the patient occluding the airway. Saliva extractor cap came off and lodged in the patient's airway. Dr (b)(6) pulled the cap out using a different suction. Pt had to go to critical care area, as a post rrt. Pt was on room air in critical care during procedure stats dropped to 60.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043205 |
| MDR Report Key | 4867453 |
| Date Received | 2015-06-18 |
| Date of Event | 2015-06-12 |
| Date Added to Maude | 2015-06-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BURKHART SALIVA EJECTORS |
| Generic Name | BURKHART SALIVA EJECTORS |
| Product Code | DYN |
| Date Received | 2015-06-18 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BURKHART |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2015-06-18 |