BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M230 SENSI-TCH 22X4-1/2

    MDR report key: 1333743 · Received January 22, 2008

    Report

    Report Number
    1017768-2009-00026
    Event Type
    Malfunction
    Date Received
    January 22, 2008
    Report Date
    January 6, 2009
    Manufacturer
    COVIDIEN
    Product Code
    BSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 01/21/2009. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN IN 2009, THAT A CUSTOMER HAD AN ISSUE WITH A SPINAL NEEDLE. CUSTOMER REPORTS THAT THE NEEDLE SEPARATED FROM THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M230 SENSI-TCH 22X4-1/2 SPINAL NEEDLE BSP COVIDIEN 8881230240 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK