MAUDE Adverse Event Report: AMD MEDICOM INC. SAFEBASICS SALIVA EJECTOR

Catalog Number	700
Medical Device Problem Code	Appropriate Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	12/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: SAFEBASICS SALIVA EJECTOR
• Common Device Name: SALIVA EJECTOR
• Manufacturer (Section D): AMD MEDICOM INC.; 1200 55th avenue; montreal, quebec H8T 3 J8; CA H8T 3J8
• MDR Report Key: 6281928
• Report Number: 9611959-2017-00001
• Device Sequence Number: 12339937
• Product Code: DYN
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 700
• Device Lot Number: 100.16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2016
• Initial Report FDA Received Date: 01/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR