MAUDE Adverse Event Report: CROSSTEX INTERNATIONAL INC. COMFORT PLUS PREMIUM SALIVA EJECTORS

Model Number	ZCB
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	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility reported a saliva ejector tip detached from the comfort plus premium saliva ejector tube during a dental procedure.The tip was not swallowed by the patient.The patient was under local anesthetic during the procedure when the saliva ejector tip was detached.It was reported the dentist performing the procedure was able to retrieve the saliva ejector tip from the patients mouth before it was swallowed.The reported event did not cause or contribute any serious injury or deterioration of health.This event could potentially lead to serious injury if it were to recur.This complaint will be monitored in the crosstex complaint handling system.
Event or Problem Description
The user facility reported a saliva ejector tip detached from the comfort plus premium saliva ejector tube during a dental procedure.The tip was not swallowed by the patient.

• Brand Name: COMFORT PLUS PREMIUM SALIVA EJECTORS
• Common Device Name: SALIVA EJECTORS
• Manufacturer (Section D): CROSSTEX INTERNATIONAL INC.; 10 ranick road; happauge NY 11788
• MDR Report Key: 10532477
• Report Number: 2433773-2020-00004
• Device Sequence Number: 14216825
• Product Code: DYN
• UDI-Device Identifier: 50732224000676
• UDI-Public: (01)50732224000676
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/14/2020

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: Health Professional
• Device Model Number: ZCB
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1