BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENCAN SPINAL NEEDLE TRAY

    MDR report key: 777964 · Received October 31, 2006

    Report

    Report Number
    2523676-2006-00092
    Event Type
    Other
    Date Received
    October 31, 2006
    Date of Event
    October 2, 2006
    Report Date
    October 24, 2006
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    HAS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS NOT MADE AVAILABLE FOR THE MANUFACTURER TO EVALUATE. WITHOUT THE ACTUAL SAMPLE, A THOROUGH EVALUATION COULD NOT BE PERFORMED. INCIDENTS OF THIS NATURE ARE GENERALLY DUE TO THE CANNULA ENCOUNTERING SOME TYPE OF TRAUMA (BONE CONTACT), WHICH STRESSED THE PART BEYOND ITS INTENDED DESIGN CAPABILITIES. HOWEVER, NO SPECIFIC CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP PER THE USER FACILITY: PENCAN SPINAL NEEDLE BROKE AT HUB WHILE IN THE PATIENTS BACK. NEEDLE WAS ABLE TO BE RETRIEVED WITHOUT ADDITIONAL SURGERY. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY INDICATED THE NEEDLE FRAGMENT WAS RETRIEVED WITHOUT INCIDENT AND THE PATIENT SUFFERED NO ADVERSE SEQUELA ASSOCIATED WITH THIS INCIDENT. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENCAN SPINAL NEEDLE TRAY PENCAN SPINAL TRAY HAS B. BRAUN MEDICAL INC. P25PTK 60862305

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other