VRV -11 (STERILE) 4003103 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-05-01 for VRV -11 (STERILE) 4003103 * manufactured by Quest Medical, Inc..

Event Text Entries

[19550752] During a routine cabg case, the vrvii was being used without any complications. At the end of the case, the perfusionist noticed a blood leak between the hood + body of the vrv. The leak did not occur during cardioplegia delivery. Leaking was minimal.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1649914-2003-00027
MDR Report Key458085
Report Source05,06
Date Received2003-05-01
Date of Report2003-05-01
Date of Event2003-03-24
Date Mfgr Received2003-03-24
Date Added to Maude2003-05-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactKATHRYN THOMPSON
Manufacturer StreetONE ALLENTOWN PARKWAY
Manufacturer CityALLEN TX 75002
Manufacturer CountryUS
Manufacturer Postal75002
Manufacturer Phone9723909800
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVRV -11 (STERILE)
Generic NameVACUUM RELIEF VALVE
Product CodeMNJ
Date Received2003-05-01
Model Number4003103
Catalog Number*
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key447066
ManufacturerQUEST MEDICAL, INC.
Manufacturer AddressONE ALLENTOWN PKWY. ALLEN TX 75002 US
Baseline Brand NameVRV -11 (STERILE)
Baseline Generic NameVACUM RELIEF VALVE
Baseline Model No4003103
Baseline Catalog No*
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
10 2003-05-01

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