BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1970915 · Received January 5, 2011

    Report

    Report Number
    3005188751-2011-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    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

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER FOR THE DEVICE IS UNKNOWN. THE CAUSE FOR THE REPORTED LOOSE VALVE IS UNKNOWN. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE VALVE OF THE TRANSSEPTAL NEEDLE WAS LOOSE. IT IS UNKNOWN IF THIS WAS NOTED DURING PREPARATION OF THE DEVICE OR AFTER INSERTION INTO THE PATIENT. THERE WERE NO CONSEQUENCES TO THE PATIENT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK