BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L25 21 GAUGE NEEDLE GUIDE/COVER KIT

    MDR report key: 657594 · Received December 21, 2005

    Report

    Report Number
    3032367-2005-00001
    Event Type
    Malfunction
    Date Received
    December 21, 2005
    Date of Event
    November 22, 2005
    Report Date
    December 20, 2005
    Manufacturer
    SONOSITE,INC.
    Product Code
    MIJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SONOSITE, INC. RECEIVED INFO FROM A CUSTOMER THAT A 21 GAUGE NEEDLE WOULD NOT PERMIT THE PASSAGE OF A STANDARD 21 GAUGE NEEDLE. WHEN THE NEEDLE GUIDE IS ATTACHED TO THE NEEDLE GUIDE BRACKET ON THE L25 TRANSDUCER, IT IS INTENDED TO FACILITATE PLACEMENT OF THE NEEDLE INTO THE SCANNING PLANE. IN THIS SITUATION, THE CLINICIAN WAS NOT ABLE TO INSERT THE NEEDLE THROUGH THE GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L25 21 GAUGE NEEDLE GUIDE/COVER KIT DISPOSABLE NEEDLE GUIDE MIJ SONOSITE,INC. NA VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other