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

Model Number 4004203

Device Problems Sticking (1597); Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The dhr for the device was reviewed and no non-conformities or deviations were associated with the manufacturing of the device.The root cause of the issue is unknown.

Event Description

The distributor reported an issue with the cpbp vacuum relief valve.This valve was integrated into a sucker line in our cardiovascular tubing kit.The report states that the valve got stuck during use by the distributor's customer and wasn't sucking any blood.This occurred during a procedure, but when they applied some pressure on the valve, it clicked and started working.There was no delay to the procedure, no patient injury, and no blood loss was reported.The device was discarded and will not be returned for evaluation.

• Brand Name: VRV II VACUUM RELIEF VALVE
• Type of Device: CPBP VACUUM RELIEF VALVE
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: tosan onosode ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 7011809
• MDR Text Key: 92796713
• Report Number: 1649914-2017-00075
• Device Sequence Number: 1
• Product Code: DWD
• UDI-Device Identifier: 10634624442037
• UDI-Public: 10634624442037
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K760894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Other
• Device Model Number: 4004203
• Device Lot Number: 053717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 11/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention