BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSSEPTAL NEEDLE, BRK 1, 71CM

    MDR report key: 1881988 · Received October 12, 2010

    Report

    Report Number
    3005188751-2010-00104
    Event Type
    Malfunction
    Date Received
    October 12, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 16, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING DEVICE RETURN. WHEN OUR INVESTIGATION HAS BEEN COMPLETED A FOLLOW UP REPORT WILL BE SUBMITTED. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 10/12/2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(4) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED A PIECE OF PLASTIC WAS VISIBLE ON THE NEEDLE TIP WHICH WAS REMOVED PRIOR TO INSERTING THE NEEDLE INTO THE PATIENT'S HEART. THERE WERE NO REPORTED CONSEQUENCES TO THE PATIENT.

    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 2804006

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK