MAUDE Adverse Event Report: MEDIVATORS INC. DEFENDO Valve and Connector Kit

Model Number	100310
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a patient procedure their defendo valve and connector kit was leaking water.The procedure was completed successfully following a short delay.No report of injury.
Additional Manufacturer Narrative
The device subject of the reported event was not returned for evaluation.Without the return of the device, an exact cause could not be determined.The device history record was reviewed and confirmed the lot subject of the event was manufactured to specifications; no abnormalities were noted.This is an isolated event for the subject lot.No additional issues have been reported.

• Brand Name: DEFENDO Valve and Connector Kit
• Common Device Name: Connector Kit
• Manufacturer (Section D): MEDIVATORS INC.; 3150 pollok drive; conroe TX 77303
• Manufacturer (Section G): MEDIVATORS INC.; 3150 pollok drive; conroe TX 77303
• Manufacturer Contact: daniel davy ; 3150 pollok dr; conroe, TX 77303 ; +1(440)259-7401
• MDR Report Key: 50005840
• Report Number: 1651395-2026-00012
• Device Sequence Number: 10382659
• Product Code: FDF
• UDI-Device Identifier: 00724995246747
• UDI-Public: (01)00724995246747(11)260501(17)290430(10)689030
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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: 100310
• Device Catalogue Number: 100310
• Device Lot Number: (10)689030
• 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: 06/23/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2026
• 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