BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1191846 · Received October 1, 2008

    Report

    Report Number
    2032545-2008-06256
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED NO SIGNIFICANT ANOMALIES. THERE WAS NOT ENOUGH INFORMATION TO DETERMINE THE ROOT CAUSE OF THE FAILURE. THE DEVICE WAS RETURNED WITH THE WHITE PLUNGER CLIP IN PLACE. THE CAPSULE TROCAR NEEDLE WAS ADVANCED BUT NO BLOOD OR TISSUE WAS PRESENT. THE PULL WIRE WAS RETRACED, RELEASING THE CAPSULE FROM THE DEVICE. SALIVA AND OTHER MATTER WERE PRESENT. THE PLUNGER WAS FULLY DEPRESSED, BUT THE BARBS FROM THE PLUNGER SHAFT WERE DAMAGED AND BENT OUTWARD PREVENTING THE PLUNGER FROM ROTATING EASILY OR RETRACTING FULLY.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED THE PRODUCT WITH NO COMPLAINT. ANALYSIS RESULTS INDICATED THAT THE CAPSULE FAILED TO ATTACH TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q198355

    Patients

    Seq Age Sex Outcome Treatment
    1