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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUEST MEDICAL, INC. RLV-2100 B VACUUM RELIEF VALVE SUCTION CONTROL VALVE

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QUEST MEDICAL, INC. RLV-2100 B VACUUM RELIEF VALVE SUCTION CONTROL VALVE Back to Search Results
Model Number 4103202
Device Problem Fluid Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 08/22/2016
Event Type  Injury  
Manufacturer Narrative
The sample was attached to 48" water head height which is approximately 1. 73 psi (89. 76mmhg), it did not leak at the umbrella valve. The sample was attached to the roller pump and tested at low speed and high speed. No leak was seen. Then the sample was tested at different pressure settings of negative and positive pressures, the valve leaked at positive pressure of 1310mmhg. These valves are designed for pressure relief at a negative pressure of -200mmhg and at a positive pressure <1300mmhg. The roller pump was ran to test for retrograde flow, the valve leaked at the pressure relief band as it is designed to do so. Evaluation in progress, not yet complete.
 
Event Description
The foreign distributor (b)(6) reported an issue encountered with the use of the cardiopulmonary suction control device from one of their customers. The report stated that the device leaked for approximately 2-3 minutes during use. The report stated the device was removed from use and a different one was used to complete the procedure. The patient was given a transfusion to address the blood loss (volume not provided) with no patient complications reported as a result of the alleged issue. The device was returned to the manufacturer for evaluation. The device is a suction control device sold in bulk non-sterile form to the distributor for additional processing prior to end-use.
 
Manufacturer Narrative
No visual or functional anomalies were found with the device sample. The valve met specification. The device history record for the applicable lot of product did not show any manufacturing or quality concerns similar to the reported complaint condition.
 
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Brand NameRLV-2100 B VACUUM RELIEF VALVE
Type of DeviceSUCTION CONTROL 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
amy clendening-wheeler
one allentown parkway
allen, TX 75002
9723326338
MDR Report Key5963860
MDR Text Key55170732
Report Number1649914-2016-00047
Device Sequence Number1
Product Code DWD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K864503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number4103202
Device Lot Number050538
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2016
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: 09/20/2016 Patient Sequence Number: 1
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