BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODMAN CO. LTD

    MDR report key: 1670955 · Received April 26, 2010

    Report

    Report Number
    2243801-2010-00006
    Event Type
    Malfunction
    Date Received
    April 26, 2010
    Date of Event
    February 24, 2010
    Report Date
    April 20, 2010
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    DYB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS RETURNED TO THE MANUFACTURER TO BE EVALUATED. THE SAMPLE WAS CONTINUITY TESTED PER SPECIFICATION. DURING CONTINUITY TESTING, IT WAS DETERMINED THAT THE DISTAL ELECTRODE DOES NOT HAVE ANY CONDUCTIVITY. FURTHER INVESTIGATION SHOWED THAT DISTAL ELECTRODE WIRE WAS BROKEN BETWEEN THE 40 CM AND 50 CM DISTANCE MARKS. THIS BREAKAGE MIGHT OCCUR DURING CATHETER HANDLING, SUCH AS CARELESS REMOVAL FROM THE TRAY OR IN PREPARATION FOR THE PROCEDURE. ALL CATHETERS ARE 100% CONTINUITY TESTED DURING THE MANUFACTURING PROCESS PRIOR TO PACKAGING AND SHIPPING. NO SPECIFIC CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    REPORTS PACING FAILURE WHILE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODMAN CO. LTD PACING CATHETER DYB B. BRAUN MEDICAL, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other