BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VRVII - CLEAR

    MDR report key: 4823294 · Received June 7, 2015

    Report

    Report Number
    1649914-2015-00043
    Event Type
    Injury
    Date Received
    June 7, 2015
    Date of Event
    May 1, 2015
    Report Date
    July 6, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    PMA / PMN Number
    K760894
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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 1649914-2015-00041 AND -00042. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366991 VRVII - CLEAR VACUUM RELIEF VALVE II DWD QUEST MEDICAL, INC. 4004203 048183

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention