BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1800040 · Received August 11, 2010

    Report

    Report Number
    3005188751-2010-00075
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 16, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED BRK NEEDLE REVEALED THE STYLET AND WAVE SPRING WERE MISSING. THE VALVE AND HANDLE WERE LOOSE AND NOT ATTACHED TO THE NEEDLE. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER FOR THE DEVICE IS UNK. A QUALITY IMPROVEMENT PROJECT WAS INITIATED TO ADDRESS MISSING WAVE SPRING ISSUES. DATE REPORT SUBMITTED TO FDA BY MFR: 08/11/2010. DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MFR: (B)(4) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE PHYSICIAN WAS INSERTING THE SYRINGE INTO THE NEEDLE HUB, THE LATERAL METALLIC STOPCOCK DETACHED.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK