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U.S. Department of Health and Human Services

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

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QUEST MEDICAL, INC. VRV-II VACUUM RELIEF VALVE CPBP SUCTION CONTROL DEVICE Back to Search Results
Model Number 4003203
Device Problems Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/28/2016
Event Type  malfunction  
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 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.
 
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Brand NameVRV-II VACUUM RELIEF VALVE
Type of DeviceCPBP SUCTION CONTROL DEVICE
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
amy clendening-wheeler
one allentown parkway
allen, TX 75002
9723326338
MDR Report Key6128194
MDR Text Key61198081
Report Number1649914-2016-00063
Device Sequence Number1
Product Code DWD
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K760894
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 10/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number4003203
Device Lot Number050044
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/27/2016 Patient Sequence Number: 1
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