MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07,company representati report with the FDA on 2015-05-04 for 450 SAL EJECTOR 3283 8881450004 manufactured by Covidien.
[5821524]
It was reported to covidien on (b)(6) 2015 that a customer had an issue with a saliva ejector. The customer states that while using on a patient, the tip disengaged. The customer further reports that nothing fell into the patient's mouth.
Patient Sequence No: 1, Text Type: D, B5
[13262126]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[31098216]
A device history record review could not be performed because a lot number was not received with the complaint. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. A sample was received for evaluation. A visual inspection was performed and the reported issue was confirmed; the tip was detached. The tubing and the tip did not contain adhesive residues. The root cause is due to no adhesive on the tubing and tip. The sample was packaged without passing through the automated pull test machine. An automated pull test was set up in the operation process for all saliva ejectors. A re-adjustment was made on the solvent applicator airline that helps maintains the consistency of the solvent application process. If additional information is received warranting further analysis, the investigation will be resumed. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2015-00048 |
| MDR Report Key | 4745556 |
| Report Source | 01,06,07,COMPANY REPRESENTATI |
| Date Received | 2015-05-04 |
| Date of Report | 2015-05-01 |
| Date of Event | 2015-04-28 |
| Date Mfgr Received | 2015-08-17 |
| Date Added to Maude | 2015-06-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 450 SAL EJECTOR 3283 |
| Generic Name | SALIVA EJECTOR |
| Product Code | DYN |
| Date Received | 2015-05-04 |
| Model Number | 8881450004 |
| Catalog Number | 8881450004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-04 |