BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PRECISIONGLIDE

    MDR report key: 3506086 · Received November 22, 2013

    Report

    Report Number
    2243072-2013-00159
    Event Type
    Injury
    Date Received
    November 22, 2013
    Date of Event
    January 1, 2013
    Report Date
    November 22, 2013
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE WAS RECEIVED AND IN THE PROCESS OF BEING EVALUATED. ONCE THE EVALUATION IS COMPLETE THE INFORMATION WILL BE SENT AS SUPPLEMENTAL. DEVICE HISTORY REVIEW WAS CONDUCTED AND NO ANOMALIES NOTED. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 3060072.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER STATED THAT DURING A NERVE BLOCK PROCEDURE IN LOWER BACK WITH A 27 X 1 1/4 NEEDLE, THE NEEDLE BROKE. THE NEEDLE WAS VERIFIED BY X-RAY BUT UNABLE TO REMOVE. ON (B)(6) 2013, THE PATIENT WAS TRANSFERRED TO A HOSPITAL. THE NEEDLE WAS REMOVED. ON AN UNKNOWN DATE, THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOR 10 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607952 BD PRECISIONGLIDE 27 G HYPODERMIC NEEDLE FMI BD 1215405

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention