BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VACUUM RELIEF VALVE II - CLEAR

    MDR report key: 4310098 · Received December 9, 2014

    Report

    Report Number
    1649914-2014-00061
    Event Type
    Injury
    Date Received
    December 9, 2014
    Date of Event
    November 12, 2014
    Report Date
    January 20, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    PMA / PMN Number
    K760894
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 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 PROCESSING INTO FINAL, STERILE PACKS. IT WAS REPORTED THAT THE VALVE LEAKED DURING SURGERY. THE END-USER REPORTED THAT THIS OCCURRED ON 3 SEPARATE OCCASIONS WITH 3 SEPARATE DEVICES. THE DISTRIBUTOR REPORTED THEY ARE FROM THEIR SAME BATCH/LOT OF PRODUCT. THERE WAS NO INFORMATION ON THE PATIENT PROVIDED. THE REPORT STATED THE DEVICE LEAKED BLOOD FROM THE DOME PORTION OF THE DEVICE. VOLUME OF LEAKED FLUID WAS NOT INDICATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. A SAMPLE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS; SEE MANUFACTURER REPORT 1649914-2014-00059.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795223 VACUUM RELIEF VALVE II - CLEAR CARDIOPULMONARY BYPASS SUCTION CONTROL VALVE DWD QUEST MEDICAL, INC. 4004203 045395

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention