BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RLV-2100B

    MDR report key: 4689195 · Received April 14, 2015

    Report

    Report Number
    1649914-2015-00016
    Event Type
    Malfunction
    Date Received
    April 14, 2015
    Date of Event
    March 17, 2015
    Report Date
    May 8, 2015
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    PMA / PMN Number
    K864503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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

    ALTHOUGH THE COMPLAINT CONDITION COULD NOT BE DUPLICATED WITH THE COMPLAINT SAMPLE, THIS COMPLAINT INFORMATION WILL BE INCLUDED IN THE ONGOING (B)(4) INVESTIGATION RELATED TO ALLEGED LEAKING VALVE DEFECTS.

    Description of Event or Problem · 1

    THE DISTRIBUTOR'S QUALITY COORDINATOR RECEIVED A REPORT OF AN ISSUE ENCOUNTERED BY THEIR CUSTOMER WITH THE SUCTION CONTROL VALVE. THE REPORT FROM THEIR CUSTOMER STATED THAT THERE WAS A LEAKING SUCTION CONTROL VALVE IN ONE OF THEIR CARDIAC CASES. THE SUCTION CONTROL VALVE IS SOLD IN NON-STERILE FORM TO THIS DISTRIBUTOR TO BE INCLUDED IN THEIR OPEN HEART PACK PRODUCT. THE INITIAL REPORT STATED THAT THE DEVICE WOULD NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS; HOWEVER, FOLLOW UP WITH THE DISTRIBUTOR FOUND THAT THEY ARE STILL TRYING TO OBTAIN THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248794 RLV-2100B CPBP SUCTION CONTROL DEVICE DWD QUEST MEDICAL, INC. 4103202 046609

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention