MAUDE Adverse Event Report: AMD MEDICOM INC. MEDICOM SAFEBASIC SALIVA EJECTORS

Model Number	700
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation was conducted at the manufacturing facility.The investigation concluded that the cause may be attributed to the welding device being temporarily suspended during production.This would occur due to the transition from production of removable caps to production of saliva injector with fixed caps and would imply inadequate line clearance.
Event or Problem Description
A product complaint was reported to amd medicom on (b)(6) 2019 for medicom safebasics saliva ejector.Item code 700 lot# 20181426.The saliva ejector is classified as a class 1 medical device under fda code dyn.Saliva ejectors are used in dentristry in order to remove saliva, blood or other debris from the mouth during dental procedures.This disposable device is connected to an active device, normally a pneumatic system suction circuit.The following information was initially reported " the blue tips are popping off in people's mouths and the tips are even off the saliva ejectors in the bags." the complaint received by amd medicom has been logged as a product quality complaint under (b)(4).

• Brand Name: MEDICOM SAFEBASIC SALIVA EJECTORS
• Common Device Name: SALIVA EJECTOR
• Manufacturer (Section D): AMD MEDICOM INC.; 2555 chemin de l'aviation; pointe-claire, quebec, canada ; CA
• MDR Report Key: 10687288
• Report Number: 9611959-2020-00001
• Device Sequence Number: 13529132
• Product Code: DYN
• UDI-Device Identifier: 10686864049231
• UDI-Public: 10686864049231
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/15/2020

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 Model Number: 700
• Device Catalogue Number: 700
• Device Lot Number: 20181426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1