BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RLV-2100 B NONSTERILE SUCTION CONTROL

    MDR report key: 3250021 · Received July 23, 2013

    Report

    Report Number
    1649914-2013-00043
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    PMA / PMN Number
    K864503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVENTORY WAS CHECKED TO SEE IF ANY STOCK OF THE SAME LOT NUMBER WAS AVAILABLE FOR EVALUATION, BUT THERE WAS NONE. 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 THAT THEY REC'D A CUSTOMER COMPLAINT REGARDING VALVE INCLUDED IN A CUSTOM PACK. THE DISTRIBUTOR'S CUSTOMER INDICATED THAT THE SUCTION CONTROL (VACUUM RELIEF VALVE) HAD LEAKED. IT WAS REPORTED THE ISSUE HAD OCCURRED A "FEW TIMES" WITH THE SAME LOT NUMBER BUT THERE WAS NO ADD'L INFO PROVIDED, OTHER THAN IN EACH INSTANCE THE VALVE WAS REPLACED WITH NO PT IMPACT. THE DEVICE WAS NOT RETURNED TO THE MFR FOR EVALUATION. ATTEMPTS TO OBTAIN ADD'L INFO WERE NOT SUCCESSFUL. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343675 RLV-2100 B NONSTERILE SUCTION CONTROL SUCTION CONTROL, INTRACARDIAC, CARDIOBYPASS DWD QUEST MEDICAL, INC. 4103202 042498

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention