MAUDE Adverse Event Report: MEDIVATORS INC. DEFENDO SINGLE USE VALVE KIT

Model Number	100322
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of this event is in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that the auxiliary adaptors from their defendo single use valve kit have been leaking water out onto the floor.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was disposed of by user facility personnel.Without the return and evaluation of the device a cause cannot be determined.The device history record was reviewed and confirmed the lot was manufactured to specifications, and no abnormalities were noted.A 1-year complaint review was performed and confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: DEFENDO SINGLE USE VALVE KIT
• Common Device Name: DEFENDO SINGLE USE VALVE KIT
• 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: 21724990
• Report Number: 1651395-2025-00004
• Device Sequence Number: 21016403
• Product Code: FDF
• UDI-Device Identifier: 00677964092992
• UDI-Public: (01)00677964092992(17)261121(10)607691
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K102581
• 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): 03/28/2025

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: 100322
• Device Lot Number: (10)607691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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