MAUDE Adverse Event Report: COVIDIEN 450 SAL EJECTOR 3283; MOUTHPIECE, SALIVA EJECTOR

Model Number 8881450004

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported during the procedure the blue tip came off and was left inside the patient's oral cavity.The health care providers were able to remove/ retrieve it.There was no patient injury.

Manufacturer Narrative

Investigation summary: a device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality prior to release of product.A physical sample was not returned for evaluation however, four photos were provided for reference.After performing a visual inspection and analysis of the photos, there appears to be a loose blue cap.Although the reported condition was observed through the photos, the issue could not be determined to be related to the manufacturing process by the photos alone; physical samples are necessary for analysis in order to confirm quality specifications.If a sample is received at a later date, the investigation will be updated.Based on the above information, an exact root cause could not be determined however a potential root cause for the reported issue could be due to worn out grippers and springs.At the end of the assembly process a pull test is performed on the tubing and tip assembly, if there is a worn-out gripper and springs, it is possible for the machine to grab the tube incorrectly.In order to address this potential root cause and to prevent any reoccurrence, the following actions were performed: an additional pull test was added, the grippers and springs were changed, the pull test was calibrated from 2 to 5 pounds and a maintenance job plan was created.This complaint will be used for tracking and trending purposes.

• Brand Name: 450 SAL EJECTOR 3283
• Type of Device: MOUTHPIECE, SALIVA EJECTOR
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11338638
• MDR Text Key: 232212700
• Report Number: 9612030-2021-02799
• Device Sequence Number: 1
• Product Code: DYN
• UDI-Device Identifier: 10884521020337
• UDI-Public: 10884521020337
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881450004
• Device Catalogue Number: 8881450004
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other