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

Model Number 700

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

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 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
• Type of Device: SALIVA EJECTOR
• Manufacturer (Section D): AMD MEDICOM INC.; 2555 chemin de l'aviation; pointe-claire, quebec, canada ; CA
• Manufacturer Contact: may kansou ; CA
• MDR Report Key: 10687288
• MDR Text Key: 240177591
• Report Number: 9611959-2020-00001
• Device Sequence Number: 1
• Product Code: DYN
• UDI-Device Identifier: 10686864049231
• UDI-Public: 10686864049231
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1