BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSSEPTAL NEEDLE, BRK SERIES, ADULT 18 GA, 71CM

    MDR report key: 2121881 · Received May 23, 2011

    Report

    Report Number
    3005188751-2011-00060
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR - ONE BRK NEEDLE WAS RECEIVED FOR EVAL WITHOUT A HANDLE OR WAVE SPRING. VISUAL INSPECTION REVEALED THE WAVE SPRING HAD DETACHED FROM THE HANDLE CAUSING THE HANDLE TO DETACH FROM THE NEEDLE. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. A QUALITY IMPROVEMENT PROJECT WAS INITIATED TO ADDRESS WAVE SPRING DETACHMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BRK NEEDLE WAS TAKEN OUT OF THE BOX AND FLUSHED WITH FLUID. THE NEEDLE WAS THEN PUT INTO POSITION IN THE RIGHT ATRIUM FOR TRANSSEPTAL PUNCTURE. WHEN THE PHYSICIAN ATTEMPTED TO INJECT DYE, THE VALVE DETACHED FROM THE END OF THE NEEDLE. IT WAS THEN DISCOVERED THAT THE U-SHAPED LOCK MECHANISM (WAVESPRING) WAS MISSING. THE NEEDLE WAS REMOVED FROM THE PT AND REPLACED WITH NO COMPLICATIONS WITH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSSEPTAL NEEDLE, BRK SERIES, ADULT 18 GA, 71CM TRANSSEPTAL BRK NEEDLE DRC ST. JUDE MEDICAL, AF DIVISION 407200 3284003

    Patients

    Seq Age Sex Outcome Treatment
    1