BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD WHITACRE SPINAL NEEDLE

    MDR report key: 2081670 · Received April 28, 2011

    Report

    Report Number
    2618282-2011-00005
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 28, 2011
    Manufacturer
    BECTON DICKINSON
    Product Code
    CAZ
    PMA / PMN Number
    K012584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR EVAL AS OF DATE OF THIS REPORT. ADDITIONAL INFO FROM THE USER FACILITY REPORT: PT GENDER: MALE, (B)(4), DEVICE NAME: 27G, 3.5 INCH SPINAL NEEDLE, (B)(4). EXPIRATION DATE: 01/2013, DEVICE RETURNED TO MFR: YES, (B)(6).

    Description of Event or Problem · 1

    FRAGMENT OF 27G X 3 1/2" WHITACRE SPINAL NEEDLE WAS BROKEN OFF IN PT AND REQUIRED SURGICAL REMOVAL. ((B)(4)). ADDITIONAL INFO FROM THE USER FACILITY REPORT: (B)(6) FEMALE WAS SCHEDULED FOR (B)(6) 2011, L KNEE MANIPULATION WITH SPINAL ANESTHESIA AND IV SEDATION ((B)(6)) AS AN AMBULATORY PROCEDURE. PROPOFOL WAS ADMINISTERED FOR SEDATION. A 27G X INCH WHITACRE NEEDLE WAS PASSED THROUGH A 20G INTRODUCER AT L3-4 VIA L PARAMEDIAN APPROACH. STYLETTE WAS WITHDRAWN W/ NO CSF NOTED. THE NEEDLE WAS THEN REMOVED. UPON REMOVAL, THE 27G WHITACRE WAS NOTED TO HAVE FRACTURED. THE PROCEDURE WAS CANCELLED. SPINE CONSULTATION AND CT WERE OBTAINED. RETAINED NEEDLE FRAGMENT WAS CONFIRMED. LATER IN DAY ON (B)(6) 2011, SPINE SURGEON (B)(6) REMOVED THE NEEDLE FRAGMENT AND SENT IT TO PATHOLOGY. ORTHOPEDIC SURGEON (B)(6) PERFORMED THE MANIPULATION AT THIS TIME AS WELL. THE PROCEDURES WERE DONE W/ GET ((B)(6)). THERE WERE NO COMPLICATIONS OF THE PROCEDURE, THE PT WAS TRANSFERRED TO THE RECOVERY ROOM AND ADMITTED TO A GENERAL INPATIENT UNIT FOR MONITORING OVERNIGHT (WHERE SHE RECEIVED A FINAL DOSE OF PROPHYLACTIC ANTIBIOTIC AND PO PERCOCET FOR PAIN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD WHITACRE SPINAL NEEDLE 27G X 3 1/2" SPINAL ANESTHESIA TRAY CAZ BECTON DICKINSON CUSTOM TRAY # 405727 GD877050 (TRAY)

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R OR LOT #| INTRODUCER WASN'T LABELED WITH IT'S OWN REFERENCE| 20G INTRODUCER ALSO THE CUSTOM TRAY