BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSSEPTAL NEEDLE, BRK 1, 71CM

    MDR report key: 1941685 · Received December 10, 2010

    Report

    Report Number
    3005188751-2010-00129
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEEDLE WAS RECEIVED WITHOUT A WAVE SPRING WHICH SECURES THE STOPCOCK VALVE TO THE NEEDLE. HOW OR WHEN THE WAVE SPRING WAS DETACHED IS UNK. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MFG REQUIREMENTS PRIOR TO SHIPMENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER INSERTION INTO THE PT, THE PHYSICIAN NOTICED THAT THE STOPCOCK WAS DETACHED. THE DEVICE WAS REMOVED FROM THE PT AND ANOTHER DEVICE WAS OBTAINED TO CONTINUE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSSEPTAL NEEDLE, BRK 1, 71CM BRK NEEDLE DRC ST. JUDE MEDICAL, AF DIVISION 407201 3131088

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK