MAUDE Adverse Event Report: CARDINAL HEALTH 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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they have a safety issue with a product that is used daily in their gastrointestinal (gi) procedures.Per customer, this is a saliva ejector that is used to suck out the saliva out of a patient¿s mouth while they are sedated, much like a dentist¿s office, unfortunately, the small plastic blue piece has been falling off very easily.The issue was noticed when used on a patient.There was no patient harm reported.The customer further stated that they are still using the product with a new protocol around pulling on the blue tip first to make sure it¿s seated and not loose.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
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 sample was not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.At this time, a corrective and preventive action is not deemed necessary.The current process is running according to product specifications, meeting all quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.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): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13471004
• Report Number: 9612030-2022-03158
• Device Sequence Number: 3887054
• Product Code: DYN
• UDI-Device Identifier: 10884521020337
• UDI-Public: 10884521020337
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2022

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
• Device Model Number: 8881450004
• Device Catalogue Number: 8881450004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown