BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COPILOT BLEEDBACK CONTROL VALVE

    MDR report key: 2842079 · Received November 21, 2012

    Report

    Report Number
    2024168-2012-07363
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 30, 2012
    Report Date
    October 30, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DTL
    PMA / PMN Number
    K991102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. ADDITIONALLY, A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UN-SPECIFIED PROCEDURE, THE COPILOT WAS LEAKING. IT IS UNKNOWN WHAT DEVICE WAS CONNECTED TO THE COPILOT. A NEW COPILOT WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COPILOT BLEEDBACK CONTROL VALVE HEMOSTATIC VALVE DTL AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1