MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-26 for SAFEBASICS SALIVA EJECTOR 700 manufactured by Amd Medicom Inc..
[66076940]
A complaint was reported to amd medicom inc. On 05-dec-2016 for medicom brand product saliva ejector item code# 700 lot number #100. 16. The mask is classified as a class 1 device, under fda code dyn, whose intended use is to supply power to and serve as a base for other dental devices, such as a dental hand piece, a dental operating light, and an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to dental chair. The following information was initially reported: "saliva ejector tip fell off possibly in patient and tips are loose and not staying on. First time this happened. Client has been using the product for years" on 07-dec-2016 client was contacted by amd medicom by phone for further information. (b)(6) from the (b)(6) hospital anesthesia department mentioned that the patient was undergoing an endoscopy procedure when the incident happened. They are still unsure if the tip fell off into the patient but they could not locate the tip anywhere and he believes there is a chance that the tip was swallowed by the patient. He mentioned the patient would have symptoms if they aspirated the tip into the lungs. He confirmed that the patient had no symptoms. He mentioned that the tips are normally stored in the bags on a shelf in the hospital. The complaint received by amd medicom has been logged as a product quality complaint under (b)(4). A request for investigation was made to the manufacturing facility, through capa (b)(4). Investigation: - review of amd medicom quality complaint records confirmed that no similar issues had been reported for item code # 700, under lot # 100. 16. - retain samples were inspected by amd medicom. The blue cap was not easily removable. - return samples were received from end-user related to the nature of the complaint. Sixty (60) units (i. E. Saliva ejectors) were received and inspected, only 09 units had blue cap that were potentially removable when manipulated. - return samples were sent to the manufacturing facility for further evaluation. Root cause: - the root cause was identified to be related to line clearance. Some removable tips from the previous production were not removed from the production line. Corrective actions: - during every production change from the manufacture of removable to fixed tips, first two minutes of production needs to be removed from the production lot. -the manufacturing facility procedure mdq/8. 2. 4/a "products monitoring and measurement" has been updated to reflect this change. In conclusion, the risk associated to the nature of complaint is considered low if it is a short term exposure to pvc which is the material the saliva ejectors are made of. Furthermore, no other complaints of this nature have been reported for this product and lot number.
Patient Sequence No: 1, Text Type: N, H10
[66076941]
Saliva ejector tip fell off possibly in patient and tips are loose and not staying on. First time this happened. Been using the product for years. Noted several in this package that tip easily removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611959-2017-00001 |
| MDR Report Key | 6281928 |
| Date Received | 2017-01-26 |
| Date of Report | 2017-01-26 |
| Date of Event | 2016-12-05 |
| Date Mfgr Received | 2016-12-05 |
| Date Added to Maude | 2017-01-26 |
| 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 | MS. DOMINIQUE ABECASSIS |
| Manufacturer Street | 1200 55 TH AVENUE |
| Manufacturer City | MONTREAL, QUEBEC H8T 3J8 |
| Manufacturer Country | CA |
| Manufacturer Postal | H8T 3J8 |
| Manufacturer Phone | 6366262 |
| Manufacturer G1 | WORLD WORK SRL |
| Manufacturer Street | VIA DEL PROGRESSO 47 MONTEBELLO |
| Manufacturer City | VICENZA, 36054 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 36054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SAFEBASICS SALIVA EJECTOR |
| Generic Name | SALIVA EJECTOR |
| Product Code | DYN |
| Date Received | 2017-01-26 |
| Returned To Mfg | 2016-12-15 |
| Catalog Number | 700 |
| Lot Number | 100.16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMD MEDICOM INC. |
| Manufacturer Address | 1200 55TH AVENUE MONTREAL, QUEBEC H8T 3J8 CA H8T 3J8 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-26 |