BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHORT INSUFFLATION/ACCESS NEEDLE 14 GA

    MDR report key: 3810398 · Received April 11, 2014

    Report

    Report Number
    9612501-2014-00105
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 27, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GDT
    PMA / PMN Number
    K961940
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING THE INITIAL INSERTION IT GOT BROKEN. OPENED ANOTHER. NO PT HARM CONFIRMED. OPERATING TIME EXTENDED: LESS THAN 30 MIN. TISSUE DAMAGE: YES. NOTHING FELL INTO THE CAVITY: NO BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221573 SHORT INSUFFLATION/ACCESS NEEDLE 14 GA DISPOSABLE SURGICAL ACCESS DEVICE GDT COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1