BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RLV-2100 VACUUM RELIEF VALVE

    MDR report key: 6445076 · Received March 29, 2017

    Report

    Report Number
    1649914-2017-00021
    Event Type
    Injury
    Date Received
    March 29, 2017
    Date of Event
    February 24, 2017
    Report Date
    February 27, 2017
    Manufacturer
    QUEST MEDICAL, INC.
    Product Code
    DWD
    UDI-DI
    20634624413225
    PMA / PMN Number
    K864503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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. 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 DISTRIBUTOR REPORTED AN ISSUE ONE OF THEIR CUSTOMERS ENCOUNTERED DURING USE OF THE CARDIOPULMONARY SUCTION CONTROL DEVICE. THE REPORT STATED THE DEVICE LEAKED IN THE WHITE LINE OF THE DISTRIBUTOR'S CUSTOM PERFUSION PACK. THE REPORT STATED THE LEAK WAS MONITORED AND THE PROCEDURE SUCCESSFULLY COMPLETED WITH NO COMPLICATIONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED EVENT. THE DISTRIBUTOR'S PERFORMANCE ANALYSIS STATED THEIR ANALYSIS OF THE DEVICE FOUND IT LEAKED AT APPROXIMATELY 400 MMHG INSTEAD OF THE SPECIFIED 1300 MMHG. THE DEVICE IS A CARDIOPULMONARY SUCTION CONTROL DEVICE SOLD IN BULK, NON-STERILE FORM TO THE DISTRIBUTOR FOR ADDITIONAL PROCESSING PRIOR TO END-USE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223920 RLV-2100 VACUUM RELIEF VALVE CARDIOPULMONARY SUCTION CONTROL DEVICE DWD QUEST MEDICAL, INC. 4103202 050538 20634624413225

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention