MAUDE Adverse Event Report: QUEST MEDICAL, INC. VRV-II VACUUM RELIEF VALVE; CPBP SUCTION CONTROL DEVICE

Model Number	4003203
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint sample was visually inspected with no anomalies found.To simulate the reported complaint condition, the valve was connected to heise gauge and tested at roller pump speed of 0.5l/min, 1l/min and 2l/min.At all speeds the valve opened at negative pressure of 149mmhg and positive pressure of 342mmhg.The reported complaint condition could not be duplicated.The device history records for the applicable lot of product were reviewed and the inspection report showed that no defect was found and rejected and no specific manufacturing yield issue was reported similar to this complaint condition.Quest medical, inc.Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Quest medical, inc.Defers to the patient's physician regarding medical history.
Event or Problem Description
The international distributor ((b)(4)) reported an issue encountered by the customer when using the vacuum relief valve.The report stated that the valve "wouldn't allow air through to provide pressure relief and blood flow through was poor".Follow-up with the complainant found that they removed the device from use and replaced it with another.There was no additional blood loss from the usual the change out of valve prolonged the procedure by approximately 5 minutes.There were no patient complications reported as a result of the alleged issue.

• Brand Name: VRV-II VACUUM RELIEF VALVE
• Common Device Name: CPBP SUCTION CONTROL DEVICE
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6128194
• Report Number: 1649914-2016-00063
• Device Sequence Number: 786719
• Product Code: DWD
• UDI-Device Identifier: 20634624432035
• UDI-Public: 20634624432035
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K760894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2016

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: Other
• Device Model Number: 4003203
• Device Lot Number: 050044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2016
• Initial Report FDA Received Date: 11/27/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention