BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDER, NEEDLE, 7 INCH,CODMAN, RYDER, CLASSIC PLUS,

    MDR report key: 2553317 · Received April 4, 2012

    Report

    Report Number
    2553317
    Event Type
    Malfunction
    Date Received
    April 4, 2012
    Date of Event
    March 29, 2012
    Report Date
    April 4, 2012
    Manufacturer
    CODMAN
    Product Code
    FCG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NEEDLE DRIVER INSERT FELL OFF THE NEEDLE DRIVER. IT WAS NOT USED ON THE PATIENT. THIS WAS IDENTIFIED BEFORE THE INSTRUMENT WAS USED. THE MFR RESPONSE IS: QA IS BEING ARRANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOLDER, NEEDLE, 7 INCH,CODMAN, RYDER, CLASSIC PLUS, NEEDLE DRIVER FCG CODMAN CODMAN RYDER CLASSIC PLUS NEEDLE HOLDER 7 INCH *

    Patients

    Seq Age Sex Outcome Treatment
    1 *