BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMUPLEX INSULATED NEEDLE

    MDR report key: 1564999 · Received November 17, 2009

    Report

    Report Number
    2523676-2009-00108
    Event Type
    Malfunction
    Date Received
    November 17, 2009
    Date of Event
    October 21, 2009
    Report Date
    December 16, 2009
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    BXN
    PMA / PMN Number
    K860126
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE REPORTED INCIDENT WAS RETURNED TO THE MANUFACTURER TO BE EVALUATED. THE NEEDLE WAS BENT AT A 90 DEGREE ANGLE APPROXIMATELY 1 1/2" FROM THE TIP OF THE CANNULA. THE HUB END OF THE NEEDLE HAD A JAGGED APPEARANCE, INDICATING THE NEEDLE BROKE OFF AT THE HUB AND DID NOT DETACH FROM THE HUB. THE HUB OF THE NEEDLE AND THE EXTENSION SET WERE NOT RETURNED FOR EVALUATION. INCIDENTS OF THIS NATURE ARE GENERALLY DUE TO THE CANNULA ENCOUNTERING SOME TYPE OF TRAUMA WHICH STRESSED THE PART BEYOND ITS INTENDED DESIGN CAPABILITIES. THIS MAY BE THE CASE IN THIS INCIDENT ESPECIALLY SINCE IT APPEARS THAT THE RETURNED PORTION OF THE NEEDLE WAS BENT ON A 90 DEGREE ANGLE AND BROKEN OFF AT THE HUB. THE SAMPLE AND ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE ACTUAL MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY. REPORTS DOING INTERSCALENE BLOCK, NEEDLE FUNCTIONED NORMALLY THROUGH PROCEDURE. ANESTHESIOLOGIST ATTEMPTED TO REMOVE NEEDLE AND HUB SEPARATED FROM NEEDLE. NECESSITATING AN INCISION BE MADE TO RETRIEVE NEEDLE UNDER FLUOROSCOPY. ALL OF NEEDLE REMOVED. PATIENT HAS BEEN IN FOR FOLLOW-UP WITH PHYSICIAN AND NO PROBLEMS FROM NEEDLE REMOVAL REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIMUPLEX INSULATED NEEDLE STIMUPLEX NEEDLE BXN B. BRAUN MEDICAL INC. NA 61071869

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R