BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, A.V. FISTULA NEEDLE, WING EATER SAFETY 15 G. JMS

    MDR report key: 2032738 · Received February 18, 2011

    Report

    Report Number
    2032738
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    August 25, 2010
    Report Date
    February 18, 2011
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FIE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    FOLLOWING THE DIALYSIS TREATMENT, THE NURSE HAD REMOVED THE DIALYSIS NEEDLE FROM THE PT AND PROCEEDED TO SLIDE THE SAFETY/PROTECTIVE COVER OVER THE NEEDLE. AS THE NURSE PICKED UP THE NEEDLE, SHE NOTICED THE TIP HAD PUNCTURED THE SIDE OF THE PROTECTIVE CAP EXPOSING AT LEAST HALF OF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, A.V. FISTULA NEEDLE, WING EATER SAFETY 15 G. JMS A.V. FISTULA NEEDLE SET JMS FIE FRESENIUS MEDICAL CARE NORTH AMERICA * 100427532

    Patients

    Seq Age Sex Outcome Treatment
    1 *