BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENCAN SPINAL NEEDLE TRAY

    MDR report key: 2081456 · Received April 12, 2011

    Report

    Report Number
    2523676-2011-00031
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 10, 2011
    Report Date
    April 11, 2011
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    BSP
    PMA / PMN Number
    K932569
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    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, A PHOTOGRAPH OF THE SAMPLE WAS RETURNED. THE PHOTOGRAPH DEPICTED THE NEEDLE BROKEN IN TWO PIECES. THE NEEDLE SEGMENT ON THE HUB END OF THE SAMPLE WAS BOWED AND THE FRAGMENTED BEVEL END OF THE NEEDLE WAS BENT ON A 45 DEGREE ANGLE AT THE POINT OF FRACTURE. BASED ON THE PHOTOGRAPH 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 PHOTOGRAPH 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

    AS REPORTED BY THE USER FACILITY: ANESTHESIOLOGIST PREPPED PATIENT FOR A C-SECTION, NEEDLE BROKE IN PATIENT. PATIENT WAS IN USUAL SITTING POSITION AND THE NEEDLE INSERTED BETWEEN /NEAR L3, L4. WENT TO WITHDRAW AND NEEDLE BROKE. APPROX 3 CM LOST IN PATIENT. WAS ABLE TO LOCATE UNDER FLUOROSCOPY AND 3 CM OF NEEDLE WAS REMOVED SURGICALLY. PATIENT WAS DISCHARGED WITH NO ILL EFFECT. THE SAMPLE WAS KEPT BUT CUSTOMER WILL NOT PART WITH SAMPLE AT THIS TIME DUE TO INSIDE INVESTIGATION BY THEIR RISK MANAGEMENT. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THE FRAGMENTED PIECE OF THE NEEDLE WAS REMOVED FROM THE PATIENT WITHOUT INCIDENT. THE PATIENT WAS DISCHARGED AND TO THE REPORTER'S KNOWLEDGE, THE PATIENT HAS SUFFERED NO ADDITIONAL ADVERSE SEQUELA ASSOCIATED WITH THE REPORTED INCIDENT. THE SAMPLE IS BEING RETAINED BY THE FACILITY'S RISK MANAGEMENT DEPARTMENT AND WILL NOT BE RETURNED FOR EVALUATION. A PHOTOGRAPH OF THE SAMPLE WAS 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 61136165

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention