BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30G DENTAL NDL

    MDR report key: 1423027 · Received March 30, 2009

    Report

    Report Number
    1017768-2009-00087
    Event Type
    Malfunction
    Date Received
    March 30, 2009
    Report Date
    March 12, 2009
    Manufacturer
    COVIDIEN
    Product Code
    DZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 03/12/2009, THAT A CUSTOMER HAD AN ISSUE WITH A DENTAL NEEDLE. CUSTOMER REPORTS NEEDLES APPEAR TO BE SHORT. AN EVALUATION OF THE SAMPLES RECEIVED AT THE PLANT, REVEALED THAT THE CANNULA WAS SLIDING INTO THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30G DENTAL NDL DENTAL NEEDLE DZM COVIDIEN 8881401072 813050

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK