BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSSEPTAL NEEDLE, BRK-1, ADULT 18GA, 98CM

    MDR report key: 2034970 · Received February 11, 2011

    Report

    Report Number
    3005188751-2011-00007
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED DEVICE REVEALED THE WAVE SPRING WAS NOT ATTACHED TO THE NEEDLE AND THEREFORE THE HANDLE/VALVE COULD NOT STAY FASTENED ON. THE HANDLE/VALVE ASSEMBLY WAS REATTACHED USING THE RETURNED WAVE SPRING BUT WAS TOO LOOSE TO SECURE THE HANDLE/VALVE ASSEMBLY. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE INITIAL MDR 2030404-2011-00010 WAS SUBMITTED UNDER AN INCORRECT MFG REPORT NUMBER AND MFG SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LOCKING MECHANISM/HUB FELL OFF THE NEEDLE AFTER IT HAD BEEN INSERTED INTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSSEPTAL NEEDLE, BRK-1, ADULT 18GA, 98CM TRANSSEPTAL BRK NEEDLE DRC ST. JUDE MEDICAL, AF DIVISION 407207 3243711

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK