BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEEDLE 30 G X 1"

    MDR report key: 4254638 · Received November 5, 2014

    Report

    Report Number
    2243072-2014-00269
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    October 21, 2014
    Report Date
    November 5, 2014
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS NOT RETURNED FOR EVALUATION. PHOTOS OF THE BROKEN NEEDLE ARE AVAILABLE AND THE INVESTIGATION WILL BE PERFORMED BASED ON THE PHOTOS PROVIDED. UPON COMPLETION OF THE INVESTIGATION, AN SUPPLEMENTAL REPORT WILL BE FILED. OF NOTE, A QUALITY NOTIFICATION REVIEW OF THE DEVICE LOT NUMBER 4032049 WAS DONE AND THERE WERE NO NOTIFICATIONS RAISED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PREPARING THE PATIENT FOR A TOTAL RIGHT KNEE REPLACEMENT SURGERY, THE ANESTHESIOLOGIST WAS USING A 30 GAUGE X 1 INCH BD NEEDLE FOR SOFT TISSUE INFILTRATION WITH A LOCAL ANESTHESIA WHEN THE NEEDLE BROKE OFF IN THE PATIENT'S MIDLINE POSTERIOR LUMBER LEVEL AT L3-L4. AN X-RAY WAS DONE WHICH SHOWED THE BROKEN NEEDLE, THE PATIENT RECEIVED PROPHYLACTIC ANTIBIOTICS, AND SURGERY WAS REQUIRED TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710263 BD NEEDLE 30 G X 1" SMALL BORE NEEDLE FMI BECTON DICKINSON 4032049

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention