MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-08-26 for PATTERSON SALIVA EJECTOR * 0894089 manufactured by Patterson Dental.
[427877]
While suctioning the patient during a gastroscopy, the patient became combative, pulled the gastroscope out, and the blue tip of the patterson saliva ejector detached in the patient's mouth. There is risk of aspiration in a sedated patient. The rn manually removed the blue tip from the sedated patient's mouth. Upper gi procedure of stomach could not be performed due to patient's intolerance. Patient had no injury. After this occurrence, all of the remaining patterson saliva ejectors were removed and replaced with flexible bronchoscopy type suction devices. A sample of the patterson saliva ejector from the same box will be sent to the branch operations manager. The device involved in the occurrence was discarded because of saliva contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 636387 |
| MDR Report Key | 636387 |
| Date Received | 2005-08-26 |
| Date of Report | 2005-08-26 |
| Date of Event | 2005-07-05 |
| Report Date | 2005-08-26 |
| Date Reported to FDA | 2005-08-26 |
| Date Added to Maude | 2005-09-23 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATTERSON SALIVA EJECTOR |
| Generic Name | SALIVA EJECTOR |
| Product Code | DYN |
| Date Received | 2005-08-26 |
| Model Number | * |
| Catalog Number | 0894089 |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 625925 |
| Manufacturer | PATTERSON DENTAL |
| Manufacturer Address | 1031 MENDOTA HEIGHTS RD ST. PAUL MN 55120 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-26 |