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

Model Number	8881450004
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that during inspection before use, they pulled the tip and the cover was removed easily.There was no patient harm was reported.
Additional Manufacturer Narrative
The device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the defect described by the customer.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Nine decontaminated samples were received at the manufacturing site for evaluation without the original packaging or lot number.Upon a visual evaluation of the sample, it was identified that only a loose blue cap was found in the received samples.The issue was confirmed.During a previous investigation for a similar issue with a similar condition, a gemba walk was completed with the multifunctional team at the manufacturing site and it has been determined that the potential root cause for the reported issue could be worn out grippers and springs.At the end of the assembly process a pull test is performed on the tubing and the tip assembly, if there is a worn-out gripper and springs it is possible for the machine to grab the tube incorrectly.As part of continuous improvements, the following actions were performed to address the reported issue: 1.Included additional red rabbits, pull test.2.Work order registered to document the changed grippers and springs.3.Work order for station calibration from 2 to 5 pounds for pull test.4.A maintenance job plan was created.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 450 SAL EJECTOR 3283
• Common Device Name: MOUTHPIECE, SALIVA EJECTOR
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10105246
• Report Number: 9612030-2020-02482
• Device Sequence Number: 16821129
• Product Code: DYN
• UDI-Device Identifier: 10884521020337
• UDI-Public: 10884521020337
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8881450004
• Device Catalogue Number: 8881450004
• Device Lot Number: 1933306964
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/25/2020
• Supplement Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 08/13/2020
• Patient Sequence Number: 1