MAUDE Adverse Event Report: QUEST MEDICAL, INC. VRV II VACUUM RELIEF VALVE; CPBP VACCUM RELIEF VALVE

Model Number	4004203
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred outside of the us.A similar device is distributed by quest medical in us.There were no patient complications resulting from the alleged issue.At the time of this report, three requests for device return have been sent to the customer but the device has not been returned for evaluation.Dhr review conducted did not show any anomalies during production of the device.A follow-up medwatch will be submitted if additional information becomes available.
Event or Problem Description
A customer in (b)(6) reported an issue encountered while using the cpbp vacuum relief valve.The report states that two valves leaked during use in a hospital.The leak was noticed at the base of the dome of the valve.The valve was replaced.There were no patient complications reported as a result of the alleged issue.
Additional Manufacturer Narrative
The device was evaluated and it functioned as intended.Leaking was observed from the pressure relief valve under the hood at approximately 9.5 psi (491 mmhg) which is within the acceptable range.The device is intended to relieve pressure at negative pressure of -150mmhg and positive pressure build up of +340mmhg (avg).A dhr review was conducted and no anomalies were found.

• Brand Name: VRV II VACUUM RELIEF VALVE
• Common Device Name: CPBP VACCUM RELIEF VALVE
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 7039483
• Report Number: 1649914-2017-00093
• Device Sequence Number: 16379800
• Product Code: DWD
• UDI-Device Identifier: 10634624442037
• UDI-Public: 10634624442037
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K760894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2018

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: 4004203
• Device Lot Number: 050999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/20/2017
• Supplement Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 01/19/2018
• 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