BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RLV-2100 B NONSTERILE SUCTION CONTROL

    MDR report key: 3659486 · Received November 26, 2013

    Report

    Report Number
    1649914-2013-00067
    Event Type
    Malfunction
    Date Received
    November 26, 2013
    Date of Event
    September 1, 2013
    Report Date
    October 31, 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). QUEST MEDICAL, INC., HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT' HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 3 OF 3. REF: 1649914-2013-00065, 1649914-2013-00066. THE DEVICE DISTRIBUTOR (B)(4) REPORTED THAT THEY RECEIVED 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 MORE THAN ONCE BETWEEN THIS LOT OF PRODUCT AND TWO OTHERS. NO SPECIFIC INFO COULD BE OBTAINED REGARDING EACH ALLEGED INCIDENT OTHER THAN IN EACH INSTANCE THE VALVE WAS REPLACED AND THE PROCEDURE COMPLETED WITH NO PT IMPACT. THE DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617739 RLV-2100 B NONSTERILE SUCTION CONTROL SUCTION CONTROL, INTRACARDIAC, CARDIOBYPASS DWD QUEST MEDICAL, INC. 4103202

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention