MAUDE Adverse Event Report: SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. ADVANTAGE SALIVA EJECTOR

Model Number	ZWWI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the reported event, product retains from the reported lot were evaluated and no issues were noted.Devices from the same lot were returned to crosstex for evaluation.Based on the evaluation, a specific root cause could not be determined.There have been no other complaints associated with this lot.No additional issues have been reported.Crosstex will continue to monitor for similar events to ensure the product continues to perform as expected.
Event or Problem Description
The user facility reported via user facility medwatch report # mw5117102 that during five different dental procedures the tip of their advantage saliva ejector broke off.In two cases, the tip detached and was swallowed by the patient.These patients were advised by the user facility to seek medical attention and let the facility know if there were any issues.In the remaining three cases, the tip detached and all components were successfully retrieved from the patient's mouth.There was no report of injury for any of the cases.

• Brand Name: ADVANTAGE SALIVA EJECTOR
• Common Device Name: SALIVA EJECTOR
• Manufacturer (Section D): SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.; 6789 west henrietta rd; rush NY 14543
• Manufacturer (Section G): SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.; 6789 west henrietta rd.; rush NY 14543
• Manufacturer Contact: daniel davy ; 6789 west henrietta rd.; rush, NY 14543 ; 4403927453
• MDR Report Key: 17008318
• Report Number: 1319130-2023-00004
• Device Sequence Number: 20720237
• Product Code: DYN
• UDI-Device Identifier: 10732224000739
• UDI-Public: 10732224000739
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2023

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
• Operator of Device: Health Professional
• Device Model Number: ZWWI
• Device Lot Number: 2072334
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown