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 in (b)(6) with the valve which is sold bulk, non-sterile to the customer for further processing into final sterile packs.A similar device is distributed by quest medical in us, hence this medwatch is being submitted.No complaint sample was returned for evaluation.A dhr review conducted showed no manufacturing anomalies related to the reported complaint.The root cause of the alleged issue is unknown.
Event or Problem Description
A report was received regarding an alleged issue encountered during use of the cpbp vacuum relief valve.The report states that there was a leak in the sucker one way valve in the yellow aortic root vent line and they had to delay running onto bypass to cut the significantly leaking valve out of the circuit.There were no reported patient complications reported as a result of the alleged issue.
Additional Manufacturer Narrative
The device was not returned for evaluation and the inventory on the lot reported has been depleted.Dhr review was conducted and no anomalies, related to the complaint condition, were found.The root cause of the alleged incident is unknown.Quest medical will continue to monitor complaints for trend.

• 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: 7527990
• Report Number: 1649914-2018-00048
• Device Sequence Number: 13809264
• 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,Followup
• Report Date (Section B): 08/17/2018

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 Health Care Professional
• Device Model Number: 4004203
• Device Lot Number: 054486 OR 054814
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 08/17/2018
• 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