BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT

    MDR report key: 2152948 · Received June 28, 2011

    Report

    Report Number
    2152948
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    April 25, 2011
    Report Date
    June 28, 2011
    Manufacturer
    COVIDIEN KENDALL
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHARMACY TECH HAD REMOVED THE COVER OF THE 16 GAUGE KENDALL MONOJECT HYPODERMIC NEEDLE. HE REMOVED THE COVER FOR THE HUB END AND ATTACHED THE HUB TO A SYRINGE. HE WAS ABOUT TO REMOVE THE COVER FOR THE NEEDLE AND FELT SOMETHING SHARP. AS IT TURNED OUT, IT WAS THE TIP OF THE NEEDLE PROTRUDING FROM THE COVER FROM THE SIDE. THERE HAD BEEN ANOTHER INCIDENT WHERE THE TIP OF THE NEEDLE PROTRUDED FROM THE SIDE. HOWEVER, THAT USER DOES NOT RECALL THE LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOJECT HYPODERMIC NEEDLE FMI COVIDIEN KENDALL 16 GAUGE *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES