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

Model Number 4004203

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.The complaint sample will be evaluated and a follow up medwatch will be submitted if additional information becomes available.

Event Description

A report was received regarding an alleged issue encountered during use of the cpbp vacuum relief valve.The report states that the device leaked during use.There were no reported patient complications resulting from the alleged issue.

Manufacturer Narrative

The device was evaluated and was found to have functioned as intended.The device is intended to relieve pressure at negative pressure of -150mmhg and positive pressure build up of +340mmhg (avg).During simulated use testing conducted on the complaint sample, leaking was observed from the pressure relief valve under the hood at approximately 242.1mmhg which is within the acceptable range.To determine if the static pressure (the head height between the patient and the valve) caused the valve to leak, the valve was connected to a water inlet at head height of about 4 ft.(89mmhg).No leak was observed through the device.The valve was later subjected to lower pressure of about 12 inches of water (22.4mmhg), no leak was observed.A dhr review was conducted and no anomalies related to the complaint condition were found.

• Brand Name: VRV II VACUUM RELIEF VALVE
• Type of Device: CPBP VACCUM 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: 7629647
• MDR Text Key: 112568684
• Report Number: 1649914-2018-00061
• Device Sequence Number: 1
• Product Code: DWD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K760894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other Health Care Professional
• Device Model Number: 4004203
• Device Lot Number: 054814
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 06/22/2018
• Supplement Dates Manufacturer Received: 06/13/2018
• Supplement Dates FDA Received: 08/17/2018
• Was Device Evaluated by Manufacturer?: 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