VRVII - CLEAR 4004203

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,08 report with the FDA on 2015-06-07 for VRVII - CLEAR 4004203 manufactured by Quest Medical, Inc..

Event Text Entries

[5842142] The device distributor reported an issue encountered by one of their customers using the cpbp vacuum relief valve. The valve is a vacuum relief valve that is sold bulk, non-sterile to the distributor for further processing into final sterile packs. The distributor reported that there were 3 separate incidents (no exact dates provided) but with the same lot of product. See also 1649914-2015-00042 and -00043. It was reported that the valve leaked during surgery with an approximate blood loss of 15-20 cc. The complaint stated the leakage was observed during bypass. There was no information regarding the patient provided except that there were no patient complications as a result of the alleged complaint. The device was not returned to the manufacturer for analysis.
Patient Sequence No: 1, Text Type: D, B5


[13346358] 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


[24665850] The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1649914-2015-00041
MDR Report Key4823292
Report Source04,08
Date Received2015-06-07
Date of Report2015-07-06
Date of Event2015-05-01
Date Mfgr Received2015-05-08
Device Manufacturer Date2015-01-05
Date Added to Maude2015-06-08
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 FDA0
Event Location0
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 NameVRVII - CLEAR
Generic NameVACUUM RELIEF VALVE II
Product CodeDWD
Date Received2015-06-07
Model Number4004203
Lot Number048183
OperatorOTHER
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
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 2015-06-07

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