MAUDE Adverse Event Report: MEDIVATORS, INC. DEFENDO DISPOSABLE SUCTION VALVE

Model Number	100316
Medical Device Problem Codes	Difficult to Open or Close (2921); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported that suction valves from their defendo valves & kits were "blocked" during patient procedures resulting in suctioning of the mucous membrane and bleeding.The users switched to a different valve to complete the procedure.No additional medical intervention was required.
Additional Manufacturer Narrative
The devices subject of the events were discarded and not returned to medivators for evaluation.Without the returned devices, a root cause could not be determined.The device history record was reviewed, and no abnormalities were noted.There have been no other complaints associated with this lot.No additional issues have been reported.
Event or Problem Description
The distributor reported that suction valves from their defendo valves & kits "can no longer be released/closed after opening" during patient procedures resulting in suctioning of the mucous membrane in the stomach and bleeding.The users switched to a different valve to complete the procedure.No additional medical intervention was required.The distributor stated the valves were used by four different doctors; however, they were unable to provide the exact number of events and devices affected.

• Brand Name: DEFENDO DISPOSABLE 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: 18266336
• Report Number: 1651395-2023-00023
• Device Sequence Number: 7900157
• Product Code: ODC
• UDI-Device Identifier: 00677964055928
• UDI-Public: 00677964055928
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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: 100316
• Device Catalogue Number: 100316
• Device Lot Number: 554142
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2022
• 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