MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-23 for 450 SAL EJECTOR 3283 8881450004 manufactured by Covidien.
[48769242]
Submit date: 06/23/2016. An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[48769243]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a saliva ejector. The customer reports that device does not fit their scope. The blue cap piece falling off in patient. No additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[50754180]
A review of the device history record could not be conducted because a lot number was not provided. Manufacturing records are routinely reviewed prior to the release of product to ensure process and product compliance. No samples were received by covidien for evaluation. Because samples were not available for evaluation, the issue reported by the customer could not be confirmed. Due to the sample has not been received for evaluation the failure mode reported could not be confirmed therefore the root cause was not identified. However in previous evaluations with the same failure mode root cause could be gun wear on dispenser that occasioned no adhesive in saliva ejector tip. Corrective action actually in the machine extruder # (b)(4) performs the 100% automated assembly of the blue tip. Begins on (b)(6) 2010, 100 % automated pull test machine was set up in performing the pull test (2. 0 lbs. ) as a minimum operation on all assembled saliva ejectors re-adjustment of solvent applicator airline that helps maintains consistency on the solvent application process. The above mentioned actions were implemented on the dates as written, without a lot number it cannot be determined if the specific device that failed per this customer complaint was manufactured prior or after the actions above listed. The maintenance of the gain kit dispenser was included in maximo system to perform periodically maintenance. 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 | 9612030-2016-00291 |
| MDR Report Key | 5745001 |
| Date Received | 2016-06-23 |
| Date of Report | 2016-06-02 |
| Date Mfgr Received | 2016-07-21 |
| Date Added to Maude | 2016-06-23 |
| 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 | MATTHEW AMARAL |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034926373 |
| 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 | 2016-06-23 |
| Model Number | 8881450004 |
| Catalog Number | 8881450004 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-06-23 |