MAUDE Adverse Event Report: PATTERSON DENTAL SUPPLY, INC. PATTERSON SALIVA EJECTORS

Catalog Number 107-3998

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2020

Event Type  malfunction  

Manufacturer Narrative

No harm to the patient was noted.An investigation was carried out by the manufacturer, and a corrective action was put in place.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 14-feb-2020 for patterson dental supply inc.Brand product saliva ejector.Item code 107-3998.The saliva ejector is classified as a class 1 medical device under fda code dyn.Saliva ejectors are used in dentistry 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 "pink saliva ejector (107-3998) as the tip has come off multiple times." the complaint received by amd medicom has been logged as a product quality complaint under (b)(4).

• Brand Name: PATTERSON SALIVA EJECTORS
• Type of Device: SALIVA EJECTOR
• Manufacturer (Section D): PATTERSON DENTAL SUPPLY, INC.; 1031 mendota heights rd.; st. paul MN 65195 3357
• Manufacturer Contact: may kansou ; CA
• MDR Report Key: 10706650
• MDR Text Key: 214805358
• Report Number: 9611959-2020-00002
• Device Sequence Number: 1
• Product Code: DYN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 107-3998
• Device Lot Number: 20190885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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