BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCIL POINT SPINAL NEEDLE

    MDR report key: 3848713 · Received May 29, 2014

    Report

    Report Number
    2245270-2014-00048
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    March 22, 2013
    Report Date
    May 14, 2014
    Manufacturer
    VYGON SA
    Product Code
    BSP
    PMA / PMN Number
    K851478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ADVERSE EVENT WAS INITIALLY REPORTED TO FDA BY (B)(4), THE NEEDLE SUPPLIER. PLEASE REFERENCE: 9681709-2013-00006. INVESTIGATION WAS COMPLETED BY THE NEEDLE SUPPLIER, (B)(4). DUE TO LACK OF RETURNED ARTICLE OR PHOTO, THE INVESTIGATION WAS ONLY PERFORMED FOR THE RETAINED SAMPLE AND MANUFACTURING RECORD. THE RESULT SHOWED NO PROBLEM AND THUS THE ROOT CAUSE FOR THE NONCONFORMITY COULD NOT BE DETERMINED. CONCEIVABLE CAUSE FOR THE NEEDLE BREAKAGE IS THE STRESS GENERATED AT THE TIP OF THE GUIDE NEEDLE AS FULCRUM POINT, WITH COMBINATION OF CONDITIONS: THE STYLET WAS REMOVED BEFORE REACHING SUBARACHNOID SPACE AND THE PUNCTURE WAS PERFORMED ONLY WITH THE OUTER NEEDLE, AND EXTRAORDINARY LOAD WAS GIVEN TO THE NEEDLE FOR UNKNOWN REASON DURING PUNCTURE.

    Description of Event or Problem · 1

    THE SPINAL NEEDLE BROKE OFF WHILE INSERTING THE NEEDLE, AT APPROXIMATELY 3 CM FROM THE TIP. THE TIP IS STILL IN THE PARAVERTEBRAL SPACE OF THE PATIENT. THERE IS ALSO A CURVE IN THE NEEDLE. THE SURGEON DID NOT HAVE LIQUID YET, SO HE HAD NOT ARRIVED IN THE SPINAL SPACE YET. THE ANESTHESIOLOGIST PERFORMED THE SPINAL PUNCTURE MEDIALLY FOR HIP SURGERY. WHILE PIERCING THROUGH THE LIGAMENTUM FLAVUM, THE PRESSURE FELL DOWN WHILE WITHDRAWING THE NEEDLE, IT TURNED OUT TO BE CURVED AND BROKEN. THE ANESTHESIST REMOVED THE STYLET BEFORE IT ENTERED IN THE SPINAL SPACE. THE INTRODUCER WAS THROWN AWAY AFTER THE PROCEDURE. THE CLIENT RESPECTED THE NORMAL PROCEDURE. THE INTRODUCER WENT IN SMOOTHLY WITHOUT ANY CONTACT WITH THE BONE. THE SPINAL NEEDLE WENT SMOOTHLY THROUGH THE INTRODUCER. THE SPINE DID NOT MOVE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316842 PENCIL POINT SPINAL NEEDLE NEEDLE, CONDUCTION ANESTHESIA BSP VYGON SA 181.05 120112AM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other