BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICROLANCE HYPODERMIC NEEDLE 25G X 5/8"

    MDR report key: 3800273 · Received May 2, 2014

    Report

    Report Number
    2243072-2014-00096
    Event Type
    Injury
    Date Received
    May 2, 2014
    Date of Event
    February 10, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR EVAL AND THEREFORE, A ROOT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS A LOT NUMBER FOR THIS INCIDENT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    FOR A LEFT KNEE ARTHROSCOPY, GENERAL ANESTHESIA WAS SCHEDULED. AT THE TIME OF THE SURGERY, THE PT PREFERRED SPINAL ANESTHESIA AND ANESTHESIA WAS SUBCUTANEOUSLY PERFORMED. DURING THE ANESTHESIA, THE SUBCUTANEOUS NEEDLE BROKE AT THE PUNCTURE SITE. THE METAL NEEDLE REMAINED IN THE PT AND ONLY THE ORANGE HUB WAS STILL CONNECTED TO THE SYRINGE TIP. SURGICAL EXPLORATION WAS REQUIRED TO LOCATE THE NEEDLE. THE NEEDLE WAS FOUND IN THE VERTEBRAL LEFT POSTERIOR PORTION OF THE L4 SPINOUS PARA MUSCLE. EXTRACTION OF THE NEEDLE COULD NOT BE PERFORMED. ARTHROSCOPY WAS RESCHEDULED TO (B)(6) 2014. A CONSULTATION OCCURRED WITH A NEUROSURGEON, WHO RECOMMENDED AND PLANNED SURGICAL REMOVAL OF THE NEEDLE UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263731 BD MICROLANCE HYPODERMIC NEEDLE 25G X 5/8" HYPODERMIC NEEDLE, 25G X 5.8" FMI BD UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention