BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINOCAN

    MDR report key: 1724610 · Received June 11, 2010

    Report

    Report Number
    2523676-2010-00042
    Event Type
    Malfunction
    Date Received
    June 11, 2010
    Date of Event
    May 12, 2010
    Report Date
    June 7, 2010
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    BSP
    PMA / PMN Number
    K820047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL NEEDLE AND HUB SAMPLE WAS RETURNED TO THE MANUFACTURER TO BE EVALUATED. THE (B)(4) NEEDLE WAS SEPARATED FROM THE (B)(4) HUB. THE OVERALL NEEDLE LENGTH MEASURED APPROXIMATELY 1.5" AND APPEARED INTACT. THE GRIT MARKING WAS EVIDENT ON THE (B)(6) NEEDLE. IT APPEARS THE NEEDLE WAS NOT PROPERLY CRIMPED IN THE (B)(4) NEEDLE HUB. HOWEVER, NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THE HOUSE RETAIN SAMPLE FOR THE REPORTED FINAL KIT WAS PULLED FOR EVAL. THE 18GA INTRODUCER NEEDLE WAS DIMENSIONALLY AND PHYSICALLY TESTED AND MET ALL INCOMING SPECIFICATIONS. THERE ARE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED CATALOG NUMBER OR LOT NUMBER. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE ACTUAL MANUFACTURER, TEGRA MEDICAL FOR FURTHER INVESTIGATION. IF ANY ADD'L PERTINENT INFO IS RECEIVED FROM TEGRA MEDICAL, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: WHEN THE ANESTHESIOLOGIST WAS WITHDRAWING INTRODUCER NEEDLE, THE NEEDLE SEPARATED FROM THE HUB. ANESTHESIOLOGIST WAS ABLE TO RETRIEVE THE NEEDLE. ADD'L INFO PROVIDED BY THE FACILITY INDICATED THE NEEDLE WAS REMOVED WITHOUT INCIDENT AND THE PT SUFFERED NO ADVERSE SEQUELA ASSOCIATED WITH THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINOCAN SPINAL NEEDLE TRAY BSP B. BRAUN MEDICAL, INC. NA 61080896

    Patients

    Seq Age Sex Outcome Treatment
    1 Other