BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN SAFETY NEEDLE

    MDR report key: 3780783 · Received April 18, 2014

    Report

    Report Number
    1915484-2014-00015
    Event Type
    Other
    Date Received
    April 18, 2014
    Report Date
    April 4, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS KENDALL
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A SAFETY NEEDLE. THE CUSTOMER REPORTS THE NEEDLE ON THE SYRINGE IS FLIMSY AND BENDS EASILY WHILE ACTIVATING THE SAFETY DEVICE. IN ONE INSTANCE IT RESULTED IN A NEEDLE STICK TO THE CLINICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238940 UNKNOWN SAFETY NEEDLE SAFETY NEEDLE FMI COVIDIEN LP, FORMERLY REGISTERED AS KENDALL UNKNOWN SAFETY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other