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

Model Number	100316
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility discarded the device subject of the event.Therefore; the device will not be returned for evaluation.The device history record of the lot subject of the event was reviewed and no abnormalities were found.Medivators tested 30 samples of current inventory for lot number 548438 and no issues were noted.A 3-year complaint review indicates this to be an isolated event.Medivators has requested additional information from the customer regarding the reported event.A follow-up report will be submitted should additional information become available.
Event or Problem Description
The user facility reported that during a patient procedure including use of a defendo disposable suction valve, there was too much suction resulting in a small hematoma.No further medical treatment was required.The procedure was completed successfully.No report of procedure delay.
Additional Manufacturer Narrative
The user facility discarded the device subject of the event, therefore, the device will not be returned for evaluation.Without the returned device, a root cause could not be determined.The customer reported the suction pump in use during the procedure was a medap bora universal power 2080.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• 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 ; 9800 59th avenue n; plymouth, MN 55442 ; 4403927453
• MDR Report Key: 14653995
• Report Number: 1651395-2022-00003
• Device Sequence Number: 4918864
• Product Code: ODC
• UDI-Device Identifier: 00677964055928
• UDI-Public: 00677964055928
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/10/2022

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 Expiration Date: 09/23/2024
• Device Model Number: 100316
• Device Lot Number: 521315
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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