MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2012-08-28 for 450 SAL EJECTOR 3283 8881450004 manufactured by Covidien.
[3049534]
It was reported to covidien on (b)(6) 2012 that a customer had an issue with a saliva ejector. The customer states during use on a pt, the blue tip detached. There was no pt harm. Per the reporter, a cannulation tube was used on the pt and the tube was fixed with a bite block. In order to provide oral care for the pt, a saliva ejector was inserted between the tube and bite block. The blue tip was slightly stuck in the bite block, then the blue tip fell off inside the pt's mouth. It did not go into the pt's throat. The bite block was detached from the pt and the blue tip was removed from the pt's mouth.
Patient Sequence No: 1, Text Type: D, B5
[10104558]
(b)(4). An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2012-00044 |
| MDR Report Key | 2722653 |
| Report Source | 01,05,06 |
| Date Received | 2012-08-28 |
| Date of Report | 2012-08-06 |
| Date of Event | 2012-08-03 |
| Date Facility Aware | 2012-08-03 |
| Report Date | 2012-08-06 |
| Date Reported to Mfgr | 2012-08-06 |
| Date Mfgr Received | 2012-08-06 |
| Date Added to Maude | 2012-11-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | ELAINE BISHOP |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524686 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 8 SUR. NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA 92173 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 92173 |
| 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 | 2012-08-28 |
| Model Number | 8881450004 |
| Catalog Number | 8881450004 |
| Lot Number | UNKNOWN |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUID TIJUANA 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-28 |