BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODMAN CO. LTD

    MDR report key: 1743287 · Received June 24, 2010

    Report

    Report Number
    2243801-2010-00008
    Event Type
    Malfunction
    Date Received
    June 24, 2010
    Date of Event
    April 13, 2010
    Report Date
    June 21, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS NOT RETURNED TO THE MANUFACTURER TO BE EVALUATED. THE HOUSE RETAIN SAMPLE FOR THE REPORTED LOT WAS VISUALLY AND PHYSICALLY TESTED PER SPECIFICATION. THE CATHETER PASSED ALL INSPECTION CRITERIA. NO BALLOON DAMAGE OCCURED. WITHOUT THE ACTUAL SAMPLE A THOROUGH EVALUATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THERE ARE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED LOT NUMBER.

    Description of Event or Problem · 1

    REPORTS THE BALLOON RUPTURED DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODMAN CO. LTD PACING CATHETER DYB B. BRAUN MEDICAL INC. NA 61065247

    Patients

    Seq Age Sex Outcome Treatment
    1 Other