BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVOFINE 8MM (30G)

    MDR report key: 645316 · Received November 9, 2005

    Report

    Report Number
    9681821-2005-00058
    Event Type
    Other
    Date Received
    November 9, 2005
    Report Date
    October 14, 2005
    Manufacturer
    NOVO NORDISK A/S - MEDICAL SYSTEMS
    Product Code
    FMI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT, RECEIVED AND REPORTED BY A NURSE AS "NEEDLE BROKE AND REMAINED IN THE ABDOMEN", CONCERNS A PATIENT TREATED WITH NOVOFINE 30G 8 MM NEEDLES DUE TO TYPE 2 DIABETES MELLITUS. REPORTEDLY, HE HAS HAD DIABETES MELLITUS FOR MANY YEARS. HE HAS INJECTING NOVOMIX 30 (DUAL-ACTING INSULIN ASPART) WITH NOVOFINE 30G 8 MM NEEDLES SINCE 2005. PREVIOUSLY, HE WAS TREATED WITH INSULATARD (LONG-ACTING HUMAN INSULIN). THE PATIENT INJECTED INSULIN ON AN UNKNOWN DATE AND FELT THE PUSHBUTTON WAS DIFFICULT TO DEPRESS. AS HE WITHDREW THE NEEDLE HE NOTICED THAT THE NEEDLE WAS BENT. HE STRAIGHTENED THE NEEDLE AND INJECTED AGAIN. THE NEEDLE BROKE OFF AND REMAINED IN THE ABDOMEN. HE WAS NO HOSPITALIZED DUE TO THE EVENT AND NO X-RAY WAS PERFORMED. HIS DOCTOR JUDGED THE NEEDLE TO REMAIN IN THE ABDOMEN SINCE IT WOULD BE HARD TO LOCATE AND THERE WOULD BE NO PROBLEM LEAVING THE NEEDLE, AND THE PATIENT DOES NOT MIND HAVING THE NEEDLE IN THE ABDOMEN. THE PATIENT HAS NOT YET RECOVERED FROM THE EVENT.9

    Description of Event or Problem · 1

    NEEDLE BROKE AND REMAINED IN THE ABDOMEN (MEDICAL DEVICE COMPLICATION). THE PT IS A TRAINED NEEDLE USER, DOES NOT RE-USE THE NEEDLES AND HAS BEEN TAUGHT IN PERFORMING AIR SHOTS PRIOR TO THE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVOFINE 8MM (30G) NEEDLE FMI NOVO NORDISK A/S - MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention