MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-11 for 450 SAL EJECTOR 3283 8881450004 manufactured by Covidien.
[26039180]
An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[26039181]
It was reported to covidien on (b)(6) 2015 that a customer had an issue with a saliva ejector. The customer states prior to use on a patient, the blue tip came off of the saliva ejector and was found inside the package. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[33194764]
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. One sample without the original package or lot number was received for evaluation. After performing visual inspection, the issue was observed; the blue tip was detached, confirming the reported issue. The root cause analysis from the sample analysis and the physical evidence observed there was no adhesive residue. It was determined that the most probable root cause was gun wear on the dispenser that resulted in no adhesive in the saliva ejector tip. As a corrective action, the machine extruder performs a 100% automated assembly of the blue tip. The above mentioned actions were implemented however, 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 taken. The gain kit dispenser was changed (b)(6)-2015. The maintenance of the gain kit dispenser was included to perform maintenance periodically. Any additional corrective and preventative actions are deemed not applicable at this time. 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 | 9612030-2015-00086 |
| MDR Report Key | 5070733 |
| Date Received | 2015-09-11 |
| Date of Report | 2015-09-02 |
| Date of Event | 2015-08-31 |
| Date Mfgr Received | 2015-12-10 |
| Date Added to Maude | 2015-09-11 |
| 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 ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 2010 EAST INTERNATIONAL SPEEDWAY BLVD. INDUSTRIAL |
| Manufacturer City | DELAND FL 32724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32724 |
| 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 | 2015-09-11 |
| Model Number | 8881450004 |
| Catalog Number | 8881450004 |
| 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 | 2015-09-11 |