MAUDE Adverse Event Report: MEDIVATORS INC DEFENDO SINGLE USE SUCTION VALVE

Model Number	100310
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation for the reported event is in process; a follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported via vigilance report to ansm that their defendo suction valve was not working prior to use in a procedure.User facility personnel obtained a new valve to complete the procedure.No report of injury.
Additional Manufacturer Narrative
Medivators contacted the customer and obtained a picture of the device subject of the event.The picture showed that valve stem was misaligned within the valve assembly.The issue was identified prior to use and a replacement valve was used to complete the procedure.To date, there have been no other complaints associated with this lot.No additional issues have been reported.

• Brand Name: DEFENDO SINGLE USE SUCTION VALVE
• Common Device Name: SUCTION VALVE
• Manufacturer (Section D): MEDIVATORS INC; 3150 pollok drive; conroe TX 77303
• Manufacturer (Section G): MEDIVATORS INC; 3150 pollok dr; conroe TX 77303
• Manufacturer Contact: daniel davy ; 3150 pollok dr; conroe, TX 77303 ; 4403927453
• MDR Report Key: 19528495
• Report Number: 1651395-2024-00016
• Device Sequence Number: 15354939
• Product Code: ODC
• UDI-Device Identifier: 00677964052453
• UDI-Public: 00677964052453
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/13/2024

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: 100310
• Device Catalogue Number: 100310
• Device Lot Number: 596805
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 08/02/2024
• Date Device Manufactured: 08/17/2023
• 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