BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20/30 PRIORITY PACK ACCESSORY KIT

    MDR report key: 3971402 · Received July 31, 2014

    Report

    Report Number
    2024168-2014-04898
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 7, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAV
    PMA / PMN Number
    K961471
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES ASSOCIATED WITH THE REPORTED LOT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN O RING IN THE ROTATING HEMOSTATIC VALVE (RHV) WAS LEAKING MORE THAN NORMAL, AND SEEMED TO PERFORM DIFFERENTLY. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448404 20/30 PRIORITY PACK ACCESSORY KIT ACCESSORY KIT MAV AV-TEMECULA-CT 4010803

    Patients

    Seq Age Sex Outcome Treatment
    1