BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1213795 · Received October 22, 2008

    Report

    Report Number
    2032545-2008-06787
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Report Date
    June 17, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 CAPSULE WAS RETURNED IN A CUP. IT WAS "CLEANED" WITH SOMETHING, THERE WAS A STRONG ODOR. THE DELIVERY SYSTEM WAS RETURNED IN TWO SEPARATE PIECES ALL BUNCHED UP IN A BAG. BLOOD WAS PRESENT ON THE DELIVERY SYSTEM WERE THE CAPSULE SHOULD HAVE BEEN. THE PLUNGER WAS FULLY DEPRESSED AND RETRACTED. IT APPEARED THAT THE CUSTOMER BROKE THE HANDLE OF THE DELIVERY SYSTEM TO DEPLOY THE CAPSULE. THE DEVICE IS INCLUDED IN THE BRAVO PH CAPSULE AND DELIVERY SYSTEM 9012B1011 (5-PACK) AND 9012B1001 (SINGLE-PACK) FIELD ACTION - FAILURE TO DETACH, PHYSICIAN COMMUNICATION (2007).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED TO THE MANUFACTURER AS A NON-COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q211006

    Patients

    Seq Age Sex Outcome Treatment
    1