BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENCAN SPINAL NEEDLE TRAY

    MDR report key: 2112428 · Received May 24, 2011

    Report

    Report Number
    2523676-2011-00047
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 18, 2011
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    BSP
    PMA / PMN Number
    K932569
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE IS BEING RETAINED BY THE FACILITY'S RISK MANAGEMENT DEPARTMENT AND WILL NOT BE RETURNED FOR EVALUATION. HOWEVER, PHOTOGRAPHS OF THE SAMPLE WERE RETURNED. THE PHOTOGRAPHS DEPICTED THE NEEDLE BROKEN IN TWO PIECES. THE NEEDLE SEGMENT ON THE HUB END OF THE SAMPLE WAS SLIGHTLY BENT AND THE FRAGMENTED BEVEL END OF THE NEEDLE WAS BENT ON A 45 DEGREE ANGLE AT THE POINT OF FRACTURE. THE STYLET WAS ALSO PHOTOGRAPHED AND APPEARED INTACT. BASED ON THE PHOTOGRAPHS PROVIDED SHOWING THE BEND IN THE CANNULA AT THE POINT OF FRACTURE AND THE BEND ON THE CANNULA AT THE HUB END OF THE NEEDLE, THE NEEDLE APPEARS TO HAVE ENCOUNTERED TRAUMA WHICH STRESSED THE PART BEYOND ITS INTENDED DESIGN CAPABILITIES. HOWEVER, WITHOUT THE ACTUAL SAMPLE A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THERE ARE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED CATALOG NUMBER OR THE REPORTED LOT NUMBER. THE PHOTOGRAPHS AND ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE ACTUAL MANUFACTURER FOR EVALUATION. IF ANY PERTINENT INFORMATION IS MADE AVAILABLE FROM THE MANUFACTURER A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    B. BRAUN PENCAN SPINAL NEEDLE WAS BEING USED DURING A PROCEDURE. AFTER ONE ATTEMPT AT INSERTING A SPINAL ANESTHETIC USING THE 27 GAGE NEEDLE, NEEDLE WAS PULLED OUT AND APPROXIMATELY 1.25" OF NEEDLE WAS MISSING. SPINAL NEEDLE INSERTION WAS NOT DIFFICULT. NO TORQUING ON NEEDLE WHATSOEVER. ANOTHER SURGEON WAS CALLED INTO ROOM FOR CONSULTATION. C-ARM IN ROOM AND X-RAYS OBTAINED. GENERAL ANESTHESIA INDUCED WITH LMA (LARYNGEAL MASK AIRWAY). KNEE SURGERY PROCEEDED AS BOARDED. THE SURGEON BELIEVES THERE IS A DEFECT IN THE NEEDLE BECAUSE IT BROKE SO EASILY. REQUIRED A SECONDARY SURGERY TO REMOVE THE NEEDLE PIECE THAT WAS RETAINED IN THE PATIENT. PATIENT WAS NOT PERMANENTLY HARMED BY THIS INCIDENT AND APPEARS TO BE DOING FINE. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). ON (B)(6) 2011 - ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED ANOTHER SURGEON WAS CALLED IN AND THE PROCEDURE TO REMOVE THE FRAGMENTED PIECE OF NEEDLE WAS PERFORMED IMMEDIATELY AFTER THE KNEE SURGERY WAS PERFORMED. THE FRAGMENTED PIECE OF NEEDLE WAS REMOVED W/O INCIDENT AND THE PATIENT SUFFERED NO ADDITIONAL ADVERSE SEQUEL ASSOCIATED WITH THE PROCEDURE. THE SAMPLE IS BEING RETAINED BY THE FACILITY'S RISK MANAGEMENT DEPARTMENT AND WILL NOT BE RETURNED FOR EVALUATION. A PHOTOGRAPH OF THE SAMPLE WILL BE FORWARDED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENCAN SPINAL NEEDLE TRAY PENCAN SPINAL TRAY BSP B. BRAUN MEDICAL, INC. NA 61150542

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other