VRV II VACUUM RELIEF VALVE 4004203

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-16 for VRV II VACUUM RELIEF VALVE 4004203 manufactured by Quest Medical, Inc..

Event Text Entries

[93165807] The event occurred outside of the us. A similar device is distributed by quest medical in us. There were no patient complications resulting from the alleged issue. At the time of this report, three requests for device return have been sent to the customer but the device has not been returned for evaluation. Dhr review conducted did not show any anomalies during production of the device. A follow-up medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10


[93165808] A customer in (b)(6) reported an issue encountered while using the cpbp vacuum relief valve. The report states that two valves leaked during use in a hospital. The leak was noticed at the base of the dome of the valve. The valve was replaced. There were no patient complications reported as a result of the alleged issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1649914-2017-00093
MDR Report Key7039483
Date Received2017-11-16
Date of Report2018-01-18
Date Mfgr Received2017-10-20
Date Added to Maude2017-11-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTOSAN ONOSODE
Manufacturer StreetONE ALLENTOWN PARKWAY
Manufacturer CityALLEN TX 75002
Manufacturer CountryUS
Manufacturer Postal75002
Manufacturer Phone9723326338
Manufacturer G1QUEST MEDICAL, INC.
Manufacturer StreetONE ALLENTOWN PARKWAY
Manufacturer CityALLEN TX 75002
Manufacturer CountryUS
Manufacturer Postal Code75002
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVRV II VACUUM RELIEF VALVE
Generic NameCPBP VACCUM RELIEF VALVE
Product CodeDWD
Date Received2017-11-16
Returned To Mfg2017-11-29
Model Number4004203
Lot Number050999
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerQUEST MEDICAL, INC.
Manufacturer AddressONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-11-16

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