BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAF-T HOLDER BLOOD CULTURE DEVICE

    MDR report key: 2468920 · Received February 22, 2012

    Report

    Report Number
    MW5024389
    Event Type
    Other
    Date Received
    February 22, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 15, 2012
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FMI
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STAFF COLLECTING BLOOD CULTURE FROM IJ LINE WHEN DEVICE REMOVED, INSIDE TIP OF BLOOD CULTURE DEVICE BROKE OFF REMAINING INSIDE THE LUMEN. IV THERAPY ASSESSED AND STATED THAT NIPPLE TIP OF CULTURE ADAPTER BROKE OFF AND WAS LODGED INSIDE ONE LUMEN OF CENTRAL LINE WHICH WAS THEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAF-T HOLDER BLOOD CULTURE DEVICE BLOOD CULTURE DEVICE FMI SMITHS MEDICAL ASD, INC. 2066820

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR