MAUDE Adverse Event Report: PATTERSON DENTAL / PATTERSON COMPANY INC. PATTERSON SALIVA EJECTOR W/ WHITE TIP SUCTION CATHETER; MOUTH PIECE SALIVA EJECTOR

Model Number 089-4097

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2018

Event Type  malfunction  

Event Description

The tip of the catheter came off while suctioning.

• Brand Name: PATTERSON SALIVA EJECTOR W/ WHITE TIP SUCTION CATHETER
• Type of Device: MOUTH PIECE SALIVA EJECTOR
• Manufacturer (Section D): PATTERSON DENTAL / PATTERSON COMPANY INC.; 1031 mendota heights rd; st. paul MN 55201
• MDR Report Key: 8064827
• MDR Text Key: 127073593
• Report Number: MW5081182
• Device Sequence Number: 0
• Product Code: DYN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 089-4097
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0