MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2015-02-25 for 450 SAL EJECTOR 3283 8881450004 manufactured by Covidien.
[5545449]
It was reported to covidien on (b)(6) 2015 that a customer had an issue with a saliva ejector. The customer reports that the blue part came off in the patient's mouth during suctioning. There was no medical intervention required. The patient was sedated when this incident occurred. The incident is more clearly defined by a covidien clinician as; the blue tip of the suction tube came off during oral suction. No medical intervention required.
Patient Sequence No: 1, Text Type: D, B5
[12793948]
(b)(4). An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[29019364]
The device history record file was reviewed indicating that product was released accomplishing all quality standard requirements. There were no non-conforming issues reported during the production of this product for a similar condition as reported in this complaint. There were 627 samples received for evaluation. Visual and functional inspections were performed and the reported issue could not be confirmed. Because the reported issue could not be confirmed, a definite root cause could not be confirmed. However, a possible root cause could be due to the sample being packaged without passing through an automated pull test machine. As part of a corrective action, the process layout was improved to assure that the assembly parts pass through the automated pull test machine 100%. A meeting was conducted for the manufacturing personnel to reinforce information regarding the use of the product as well as the reported issue. 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 | 9612030-2015-00013 |
| MDR Report Key | 4544200 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-02-25 |
| Date of Report | 2015-02-23 |
| Date Mfgr Received | 2015-08-20 |
| Date Added to Maude | 2015-03-30 |
| 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 | 2015-02-25 |
| Model Number | 8881450004 |
| Catalog Number | 8881450004 |
| Lot Number | 424604864X |
| 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 | 2015-02-25 |