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

Model Number	4004203
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event occurred in (b)(6).A similar device is distributed by (b)(4) in us.There were no patient complications resulting from the alleged issue.The device was received and evaluated via simulated use testing.No leaks were observed when the device was primed.The device started leaking at a positive pressure of 13.11psi or 677.98 mmhg.The device is designed to relieve pressure at negative pressure of -200 mmhg and positive pressure buildup of <1300 mmhg (avg).The device functioned as intended.Dhr review conducted showed no issues during manufacturing.
Event or Problem Description
The device distributor in (b)(4) reported an issue encountered by one of their customers using the cpbp vacuum relief valve.The valve is a vacuum relief valve that is sold bulk, non-sterile to the distributor for further processing into final sterile packs.The distributor reported they received a complaint which stated the valve leaked during use.This occurred during a procedure, and the clinicians continued to use the device to complete the procedure.There were no patient complications reported as a result of the alleged issue.The device was returned for evaluation.

• 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: 7011812
• Report Number: 1649914-2017-00076
• Device Sequence Number: 16496641
• Product Code: DWD
• UDI-Device Identifier: 10634624442037
• UDI-Public: 10634624442037
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K760894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2017

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: 052241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 11/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1