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

Model Number 8881450004

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 08/31/2015

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a saliva ejector.The customer states prior to use on a patient, the blue tip came off of the saliva ejector and was found inside the package.There was no patient involvement.

Manufacturer Narrative

A review of the device history record could not be conducted because a lot number was not provided.Manufacturing records are routinely reviewed prior to the release of product to ensure process and product compliance.One sample without the original package or lot number was received for evaluation.After performing visual inspection, the issue was observed; the blue tip was detached, confirming the reported issue.The root cause analysis from the sample analysis and the physical evidence observed there was no adhesive residue.It was determined that the most probable root cause was gun wear on the dispenser that resulted in no adhesive in the saliva ejector tip.As a corrective action, the machine extruder performs a 100% automated assembly of the blue tip.The above mentioned actions were implemented however, without a lot number it cannot be determined if the specific device that failed per this customer complaint was manufactured prior or after the actions taken.The gain kit dispenser was changed (b)(6)-2015.The maintenance of the gain kit dispenser was included to perform maintenance periodically.Any additional corrective and preventative actions are deemed not applicable at this time.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 450 SAL EJECTOR 3283
• Type of Device: SALIVA EJECTOR
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; 2010 east international speedway blvd.; industrial; deland FL 32724
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5070733
• MDR Text Key: 26039180
• Report Number: 9612030-2015-00086
• Device Sequence Number: 1
• Product Code: DYN
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8881450004
• Device Catalogue Number: 8881450004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1