BEUDAMED
    FDA Adverse Event Other Summary report: N

    NA

    MDR report key: 1038755 · Received May 1, 2008

    Report

    Report Number
    2647836-2008-00004
    Event Type
    Other
    Date Received
    May 1, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 25, 2008
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FMI
    PMA / PMN Number
    K895109
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICES IN THE INCIDENTS WERE NOT RETURNED TO THE MANUFACTURER TO BE EVALUATED. WITHOUT THE ACTUAL SAMPLES, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. HOWEVER, AN INVESTIGATION INTO A PREVIOUS INCIDENT AGAINST THIS PART, REPORTED BY THIS SAME FACILITY COULD NOT BE DUPLICATED. THE HOUSE RETAIN SAMPLES FOR THE REPORTED PART WERE VISUALLY AND PHYSICALLY TESTED PER SPECIFICATION AND PASSED. ALL AVAILABLE INFORMATION HAVE BEEN PROVIDED TO THE ACTUAL MANUFACTURER, ICU MEDICAL, INC. IF ANY PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE FACILITY: THE NEEDLE IS PULLING OUT OF THE TUBING CAUSING A CHEMO SPILL. NO PATIENT INJURY. NO SAMPLES FOR RETURN. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THAT THE NEEDLE IS NOT PULLING OUT OF THE TUBING, ACTUALLY THE PART IS CRACKING, CAUSING LEAKAGE. NO ONE HAS SUFFERED ANY ADVERSE SEQUELA ASSOCIATED WITH THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA PROTECTED NEEDLE FMI B. BRAUN MEDICAL INC. NA 60956134

    Patients

    Seq Age Sex Outcome Treatment
    1 Other