BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1842641 · Received September 1, 2010

    Report

    Report Number
    3005188751-2010-00081
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    ST. JUDE MEDICAL, AF DIV
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED NEEDLE REVEALED THE WAVE SPRING WAS DETACHED FROM THE BACK SIDE OF THE HANDLE. THE VALVE/HANDLE WAS DETACHED FROM THE NEEDLE. THE WAVE SPRING WAS SUCCESSFULLY RE-ATTACHED TO THE HANDLE, SECURING THE HANDLE TO THE NEEDLE. THE HANDLE WAS NOT LOOSE. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. A QUALITY IMPROVEMENT PROJECT WAS INITIATED TO ADDRESS THE WAVE SPRING ISSUES (E.G. DETACHING, LACK OF TENSION, MISSING). DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: (B)(4) 2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(4) 2010.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER THE NEEDLE WAS INSERTED INTO THE PATIENT, THE WAVE SPRING WAS FOUND TO BE LOOSE AND EASILY DETACHED FROM THE VALVE OF THE BRK NEEDLE. WHEN THE PHYSICIAN NOTED THIS, HE REMOVED BOTH THE NEEDLE AND THE SHEATH WITH NO CONSEQUENCES TO THE PATIENT. THE DOCTOR REPLACED THE NEEDLE AND SHEATH WITH ANOTHER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    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 DIV 407200 3079567

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR