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

Model Number 8881450004

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2024

Event Type  Injury  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event 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.

• Brand Name: 450 SAL EJECTOR 3283
• Type of Device: 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
• MDR Text Key: 338375862
• Report Number: 9612030-2024-00050
• Device Sequence Number: 1
• Product Code: DYN
• UDI-Device Identifier: 10884521020337
• UDI-Public: 10884521020337
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• 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
• Date Manufacturer Received: 03/12/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1