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	03/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that during oral suctioning, the plastic part on the edge came off.The patient swallowed the fallen part accidentally, and, eventually it was retrieved with an endoscope.There was no additional medication or no further medical treatment.The patient appeared to be advanced age since he/she has no teeth at all.The period of use was a couple of minutes.There was no infection.It did fall/retain in the body.There is no further information available.
Additional Manufacturer Narrative
A sample was received at the plant for the investigation.Because a lot number was not provided, the device history record could not be performed.Upon a visual evaluation of the sample, the reported issue was confirmed; detachment was observed between the tube and connector.A root cause was unable to be determined.Actions have been taken to address the reported condition.A quality alert was also issued to alert manufacturing personnel as part of the quality containment.

• Brand Name: 450 SAL EJECTOR 3283
• Common Device Name: MOUTHPIECE, SALIVA EJECTOR
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west steet; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18960545
• Report Number: 9612030-2024-00050
• Device Sequence Number: 8161208
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8881450004
• Device Catalogue Number: 8881450004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 07/22/2024
• 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