BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NEEDLES NANO

    MDR report key: 6039494 · Received October 17, 2016

    Report

    Report Number
    MW5065486
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 17, 2016
    Manufacturer
    BD
    Product Code
    FMI
    UDI-DI
    08290320883
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OTHER SERIOUS/IMPORTANT MEDICAL INCIDENT: STICK MULTIPLE TIMES BC PEN. BD PEN NEEDLES DEFECTIVE. NO TOUJEO COMES OUT AND PT HAD TO USE 10 DIFFERENT PEN NEEDLES IN 1 SINGLE INJECTION. FREQUENCY: AT BEDTIME. DATE THE PERSON FIRST STARTED TAKING OR USING THE PRODUCT: (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684412 BD PEN NEEDLES NANO BD FMI BD 5112145 08290320883
    684413 BD PEN NEEDLES NANO BD FMI BD 5112145 08290320883
    684414 BD PEN NEEDLES NANO BD FMI BD 5112145 08290320883
    684415 BD PEN NEEDLES NANO BD FMI BD 5112145 08290320883
    684416 BD PEN NEEDLES NANO BD FMI BD 5112145 08290320883
    684417 BD PEN NEEDLES NANO BD FMI BD 5112145 08290320883
    684418 BD PEN NEEDLES NANO BD FMI BD 5112145 08290320883
    684419 BD PEN NEEDLES NANO BD FMI BD 5112145 08290320883
    684420 BD PEN NEEDLES NANO BD FMI BD 5112145 08290320883
    684421 BD PEN NEEDLES NANO BD FMI BD 5112145 08290320883

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other