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

Catalog Number 107-3964

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/29/2022

Event Type  Injury  

Event Description

Blue suction tip of the saliva injector came off while an unconscious patient was being suctioned.

Event Description

Additional information received from reporter on 3/25/2024 for report mw5115008.New: reference mw5115008: this is an update to an existing mdr to add information that was obtained following the original submission.New information will be preceded with "new" to identify new information being added to the report.Problem: blue suction tip came off while an unconscious patient was being suctioned.Tip piece was safety retrieved.Manufacturer evaluation results: since the customer haven't provided with the lot number, no investigation could be conducted for this item.However, a previous similar issue was observed with this product on 14-nov-2022.The manufacturer provided an investigation and a capa.The manufacturer confirmed that jun-2022, an improvement action was carried out to prevent the tip from falling out from the ejector: a photocell has been installed to monitor the correct application of the adhesive substance that fixes the tip furthermore, a pneumatic reject system was put in place to improve the rejection of non conforming cannulas.

Event Description

Additional information received from reporter on 4/3/2024 for report mw5115008.New: reference mw5115008: this is an update to an existing mdr to add information that was obtained following the original submission.New information will be preceded with "new" to identify new information being added to the report.Problem: blue suction tip came off while an unconscious patient was being suctioned.Tip piece was safely retrieved.Manufacturer evaluation results: since the customer haven't provided with the lot number, no investigation could be conducted for this item.However, a previous similar issue was observed with this product on 14-nov-2022.The manufacturer provided an investigation and a capa.The manufacturer confirmed that jun-2022, an improvement action was carried out to prevent the tip from falling out from the ejector: a photocell has been installed to monitor the correct application of the adhesive substance that fixes the tip furthermore, a pneumatic reject system was put in place to improve the rejection of non conforming cannulas.

• Brand Name: PATTERSON SALIVA EJECTORS
• Type of Device: MOUTHPIECE, SALIVA EJECTOR
• Manufacturer (Section D): PATTERSON DENTAL SUPPLY INC.; st. paul MN 55120
• MDR Report Key: 16398127
• MDR Text Key: 309880097
• Report Number: MW5115008
• 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: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 107-3964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other