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

Model Number	4103202
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported an issue one of their customers encountered during use of the cardiopulmonary suction control device.The report stated the device leaked from the white line of the distributor's custom perfusion pack.The report stated the leak was observed during priming, so it was replaced before the procedure began.There were no patient complications reported as a result of the alleged event.The device is a cardiopulmonary suction control device sold in bulk, non-sterile form to the distributor for additional processing prior to end-use.It is not known if the device is available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Visual examination of the returned complaint sample found no anomalies.The sample was primed by connecting to a rotary pump and circulating water at 1lpm.There were no leaks found.The sample was tested using in-line uson tester under normal production settings, and the sample passed at both forward and retro flow.The valve functioned as intended with no leakages found.The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.

• Brand Name: RLV-2100 VACUUM RELIEF VALVE
• Common Device Name: CARDIOPULMONARY SUCTION CONTROL DEVICE
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• MDR Report Key: 6474096
• Report Number: 1649914-2017-00036
• Device Sequence Number: 10975508
• Product Code: DWD
• UDI-Device Identifier: 20634624413225
• UDI-Public: 20634624413225
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K864503
• 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): 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 4103202
• Device Lot Number: 050937
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/07/2017
• Supplement Report FDA Received Date: 05/09/2017
• 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