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 2018-01-08 for VRV-II VACUUM RELIEF VALVE 4004203 manufactured by Quest Medical, Inc.

Event Text Entries

[96857995] There were no patient complications resulting from the alleged incident. An investigation will be conducted and a follow-up medwatch will be submitted if additional information is received.
Patient Sequence No: 1, Text Type: N, H10


[96857996] A report received states that the valve leaked from the top during bypass with blood loss between 30cc and 50cc. The valve was replaced. No patient complications were reported at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1649914-2018-00011
MDR Report Key7173835
Date Received2018-01-08
Date of Report2018-01-18
Date Mfgr Received2017-12-22
Device Manufacturer Date2017-09-06
Date Added to Maude2018-01-08
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 SUCTION CONTROL DEVICE
Product CodeDWD
Date Received2018-01-08
Returned To Mfg2018-01-03
Model Number4004203
Lot Number054017
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
10 2018-01-08

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