BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VRVII- CLEAR

    MDR report key: 4558738 · Received March 2, 2015

    Report

    Report Number
    1649914-2015-00011
    Event Type
    Malfunction
    Date Received
    March 2, 2015
    Date of Event
    November 28, 2014
    Report Date
    March 10, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    PMA / PMN Number
    K760894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    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.

    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 FOREIGN DEVICE DISTRIBUTOR (B)(6) 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 PROCESS INTO THEIR FINAL STERILE SURGICAL PACKS. THE REPORT STATED THAT DURING THE PROCEDURE THIS VALVE FAILED TO REMAIN A ONE-WAY FUNCTION. THE REPORT STATED "IT WAS WORKING BOTH WAYS" BUT THAT THE DEVICE WAS USED TO CONTINUE THE PROCEDURE WITH NO DELAYS AND WITH NO BLOOD LOSS. THERE WAS NO PATIENT INFORMATION PROVIDED EXCEPT THAT THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED COMPLAINT. THE DEVICE WAS DISCARDED BY THE END-USER AND NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142100 VRVII- CLEAR VACUUM RELIEF VALVE II DWD QUEST MEDICAL, INC. 4004203 046736

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention