RVL-2100 B VACUUM RELIEF VALVE 4103202

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-21 for RVL-2100 B VACUUM RELIEF VALVE 4103202 manufactured by Quest Medical, Inc..

Event Text Entries

[24681847] Quest medical, inc. Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. Quest medical, inc. Defers to the patient's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10


[24681908] The foreign (mexican) product distributor reported an issue encountered by one of their customers with the cardiovascular valve. The report stated the perfusionist attempted to investigate/isolate the source of the issue in the circuit and determined there was restricted flow in the one-way valve. As a result of the alleged issue, the patient was taken off of bypass and the valve was replaced. The report stated the procedure was completed with no patient complications. The device lot number was not recorded and is unknown at the time of this report. The device was returned to the manufacturer for analysis.
Patient Sequence No: 1, Text Type: D, B5


[27419435] Visual inspection with and without magnification did not show any defects. The valve was attached to a roller pump for functional testing and functioned as per specification. The complaint condition could not be duplicated. The applicable lot number for the part was never provided and could not be determined.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1649914-2015-00058
MDR Report Key5022221
Date Received2015-08-21
Date of Report2015-09-04
Date of Event2015-07-24
Date Mfgr Received2015-07-24
Date Added to Maude2015-08-21
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 ContactMRS. AMY CLENDENING-WHEELER
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 Report3

Device Details

Brand NameRVL-2100 B VACUUM RELIEF VALVE
Generic NameCARDIOVASCULAR SUCTION CONTROL VALVE
Product CodeDWD
Date Received2015-08-21
Returned To Mfg2015-08-04
Model Number4103202
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 2015-08-21

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