BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS KIT 10 GAUGE - DIAMOND TIP/END-OPENING

    MDR report key: 6182579 · Received December 7, 2016

    Report

    Report Number
    6182579
    Event Type
    Injury
    Date Received
    December 7, 2016
    Date of Event
    October 11, 2016
    Report Date
    November 8, 2016
    Manufacturer
    SYNTHES USA, LLC
    Product Code
    FCG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DR. (B)(6) WAS PLACING THE JAMSHIDI NEEDLES AND WHEN TRYING TO REMOVE IT THE TIP OF THE OUTER CANNULA BROKE OFF IN THE PATIENT. THIS HAPPENED WITH TWO NEEDLES. ALL PARTS WERE RETRIEVED AND CONFIRMED WITH X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804607 ACCESS KIT 10 GAUGE - DIAMOND TIP/END-OPENING JAMSHIDI NEEDLE FCG SYNTHES USA, LLC 16G15-1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R