MAUDE Adverse Event Report: MEDIVATORS INC. DEFENDO DISPOSABLE BIOPSY VALVE

Model Number	100301
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported 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 fluid sprays from the top and bottom of their defendo disposable biopsy valve cap.The fluid was reported on the floor and "splashed" on an employee.No report of injury or procedure delay.
Additional Manufacturer Narrative
The device subject of the event was not available for evaluation.Without the return and evaluation of the device, the cause of the reported event cannot be determined.The user facility was unable to provide the lot number for the defendo disposable biopsy valve; therefore, a review of the device history record could not be performed.Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.No additional issues have been reported.

• Brand Name: DEFENDO DISPOSABLE BIOPSY VALVE
• Common Device Name: BIOPSY VALVE
• 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
• MDR Report Key: 22798584
• Report Number: 1651395-2025-00016
• Device Sequence Number: 12833814
• Product Code: ODC
• UDI-Device Identifier: 00677964060212
• UDI-Public: (01)00677964060212
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K090851
• 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): 08/13/2025

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: 100301
• Device Catalogue Number: 100301
• 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: 07/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/03/2025
• 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