BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISYSTEMS HEMODIALYSIS FISTULA NEEDLE SET

    MDR report key: 1851337 · Received September 23, 2010

    Report

    Report Number
    2919260-2010-00003
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 21, 2010
    Report Date
    August 25, 2010
    Manufacturer
    MEDISYSTEMS CORP.
    Product Code
    FIE
    PMA / PMN Number
    K910734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS PENDING AT THE TIME OF SUBMITTING INITIAL 30 DAY MEDWATCH. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    USER FACILITY REPORTS EVENT IN WHICH THE NEEDLE CANNULA SEPARATED FROM THE HUB ON ONE OF THE TWO NEEDLES IN USE. THIS OCCURRED AT TERMINATION OF TREATMENT WHEN THE NEEDLE WAS BEING REMOVED FROM THE PT'S VASCULAR ACCESS SITE. THE PT'S CARE GIVER USED TWEEZERS TO REMOVE THE CANNULA FROM THE PT'S ACCESS. THERE WAS NO INJURY OR OTHER ADVERSE EVENT OUTCOME TO THE PT. THE COMPLAINT SAMPLE HAS BEEN RETURNED TO THIS MFR AND INVESTIGATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISYSTEMS HEMODIALYSIS FISTULA NEEDLE SET HEMODIALYSIS FISTULA NEEDLE FIE MEDISYSTEMS CORP. NA 8513F17

    Patients

    Seq Age Sex Outcome Treatment
    1