MAUDE Adverse Event Report: SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. HVE (HIGH VOLUME EVACUATOR) TIPS; SLOTTED EVACUATOR TIPS

Model Number	22357410
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that their slotted evacuator tips are abrasive and cutting patient's lips.It is unknown if the patient's received medical treatment.
Additional Manufacturer Narrative
Crosstex has made multiple attempts to obtain additional information from the customer regarding the reported event.To date, we have not received a response.As no additional information was provided regarding the reported event, a root cause could not be determined.Crosstex will continue to monitor for similar events.No additional issues have been reported.

• Brand Name: HVE (HIGH VOLUME EVACUATOR) TIPS
• Common Device Name: SLOTTED EVACUATOR TIPS
• 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: 18247340
• Report Number: 1319130-2023-00014
• Device Sequence Number: 17919372
• Product Code: EHZ
• UDI-Device Identifier: 10732224000579
• UDI-Public: 10732224000579
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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: 22357410
• Device Lot Number: 22740091 & 20908322
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 02/19/2024
• 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